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5 years, 1 month ago

The vast and rapidly growing burden of diabetic foot ulcers and amniotic tissue

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diabetic foot
diabetic foot clinic
diabetic foot disease
diabetic foot management
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  • Diabetic foot ulcers (DFUs) are a result of diabetes complications and can lead to amputations and death
  • Scientists and clinicians struggle to reduce the vast and escalating burden of DFUs
  • In wealthy countries like the UK there are specialist multidisciplinary diabetic foot clinics
  • New and innovative therapies are beginning to emerge, which accelerates the rate of complete wound closure for DFUs
  • Notwithstanding new products coming to market, the best therapy is prevention
  
The vast and rapidly growing burden of diabetic foot ulcers and amniotic tissue
 
This Commentary discusses diabetic foot ulcers (DFUs) within the context of chronic wounds. Although chronic wounds tend to be an overlooked area of medicine and do not feature prominently in the popular media; NHS England, spends £5bn a year treating 2m patients with chronic wounds. The incidence rates of people affected with wounds are rising fast and some experts suggest that nearly 60% of all wounds become chronic. According to Una Adderley, a wound expert and Director of NHS England’s National Wound Care Strategy Programme, therapy in England for chronic wounds is patchy and suboptimal, “leading to non-healing or delayed healing (which) increases the number of people living with chronic wounds. Too many people are receiving care for which there is little evidence that it works and too few are receiving care for which there is strong evidence that it works”.
 
According to a 2019 report by the consulting firm MarketsandMarkets the global wound care market in 2019 is estimated to be US$20bn and projected to reach US$25bn by 2024. Market drivers include the vast and fast-growing incidence rates of hard-to-heal chronic wounds, a large proportion of which are associated with diabetes, increasing R&D spending, technological developments, the growing use of regenerative medicine in wound care, recent advances in molecular data that have contributed to genome sequencing, and the increasing use of AI in the management of wound care solutions. The chronic wound care markets of North America and Europe are expected to grow at a CAGR of ~4.5% for the next 5 years, but the highest CAGR is expected in Asia where the vast pool of patients is increasing significantly, and favourable reimbursement policies are expected to persist in the region for the next decade. 

When accompanied by an underlying condition such as diabetes, chronic wounds in the form of DFUs, are challenging to heal and have a deleterious effect on your quality of life: you experience pain, suffering, disfigurement, anxiety impaired mobility, malodour and social isolation. Because the prevalence of diabetes is increasing worldwide, DFUs have become a large, severe and growing public health issue as described in two research papers published in 2019.
 
One, published in the May 2019 edition of Diabetic Medicine, reports findings of an 18 year study of DFUs, and suggests that although current therapies in the UK result in better than previously reported survival in persons < 65 years (10 year survival is 85%), treatments fail to, “reduce recurrent incidence (of DFUs and) cumulative prevalence of all ulcers continues to increase”; from 20.7 to 33.1 per 1,000 persons between 2003 to 2017. The second paper, published in the January-March 2019 edition of the International Journal of Applied Basic Research, report sfindings of a prospective Indian study of 63 patients >18 with DFUs and shows the increase in the severity of DFUs and the consequent increase in the rate of hospital readmissions, amputations and mortality.
 
In this Commentary
 
This Commentary briefly describes the increasing prevalence of diabetes and its complications, the causes and symptoms of DFUs, which benefit from specialist multidisciplinary clinics and strategies to prevent them deteriorating to the point where the only therapy is amputation. We complete the Commentary by briefly mentioning how human amniotic membrane is being used in the current standard of care as a therapy for DFUs and describe the findings of two amniotic membrane studies. Notwithstanding these and other new product offerings coming to market, which accelerate the closure of DFUs, the most efficacious therapy for DFUs is prevention.
 
Diabetes and DFUs
 
Diabetes is a chronic disease that occurs either when your pancreas does not produce enough insulin or when your body cannot effectively use the insulin it produces. Insulin is a hormone that regulates your blood sugar level. High blood sugar levels (hyperglycaemia) is a common effect of uncontrolled diabetes and can lead to serious complications, which include blindness, kidney failure, heart attacks, stroke, diabetic foot ulcers (DFUs), and lower limb amputations. According to the World Health Organization, the global prevalence of diabetes among people >18 has risen from 4.7% in 1980 to 8.5% in 2014. Today, some 422m people worldwide have diabetes, which has increased from 108m in 1980. There is expected to be some 642m people >18 living with diabetes by 2040.
 
If you have diabetes you are prone to ulcers because your increased blood sugar levels create thick, sticky blood, which can lead to  peripheral artery disease (PAD), neuropathy (a loss of sensation due to nerve damage), and/or problems with circulation due to damage to your small blood vessels, which reduce your body’s ability to heal injuries.
 
Signs and symptoms of DFUs include numbness in your toes and a loss of feeling in your feet, painful tingling sensations, blisters, minor abrasions and cuts without pain that do not heal, skin discoloration and temperature changes  With a loss of sensation, a minor injury to your foot can go unnoticed and untreated, and quickly lead to an ulcer. If you are living with diabetes, ulceration is an ongoing challenge. Only about 66% of DFUs eventually heal without surgery. If you have had a foot ulcer you are at increased risk of further ulceration. Studies suggest that around 25% of people living with diabetes who become ulcer-free have developed new ulcers within 3 months, and 34% to 41% within 12 months. Some foot ulcers are painful, and treatment often requires that you spend a significant amount of time visiting clinics to frequently change your wound dressings. The poor prognosis of DFUs is often attributed to other complications of diabetes such as peripheral neuropathy, peripheral vascular disease and persistent hyperglycaemia. Managing diabetic foot ulcers is a major challenge for healthcare systems globally and the main cause of more than half of nontraumatic lower limb amputations: every 30 seconds in the world, a lower limb is amputated due to diabetes. Amputations have life-altering repercussions for patients and represent a significant burden for the healthcare industry as a whole. Between 0.03% and 1.5% of people with DFUs require an amputation and most amputations start with ulcers.
 
Major amputations and mortality rates
 
For major amputations, the prognosis is poor because your other limb is at risk.  Research suggests that only around 50% of patients survive for two years after major diabetes related amputations. The one-year mortality rate has been estimated at 32.7% after major amputation and 18.3% after minor amputation if you have diabetes. Five-year cumulative mortality for patients with diabetes undergoing a first major amputation has been estimated at 68% to 78.7%. Thus, if you have diabetes and a DFU you have almost a 50% chance of being dead within five years, which is significantly higher than for people with either breast (18%) or prostate (8%) cancers.
 
The UK
 
In the UK some 70,000 to 90,000 people living with diabetes have DFUs at any one time. If you have diabetes you are about 23 times more likely to experience an amputation than someone without diabetes. In England, diabetes leads to more than 9,000 lower limb amputations each year. Each week in England some 169 people undergo an amputation procedure as a result of diabetes. Analysis by the charity Diabetes UK found that between 2014 and 2017, 26,378 people had lower limb amputations linked to diabetes, which represented a 19% rise from 2010 to 2013. Diabetes affects almost 3.7m people in the UK. In 2017 NHS England launched a special transformation fund aimed at improving patients with diabetes access to specialist multidiscipline foot care clinics to help avoid amputations.
 
Specialist multidisciplinary treatment centres
 
In the video below Hisham Rashid, Consultant Vascular Surgeon at King’s College Hospital, London, describes a DFU and explains why they benefit from specialist multidisciplinary treatment centres. “DFUs have similar features to other ulcers, and often present in the toes and heal areas of the foot with the loss of skin and an exposed base with infection and necrosis. The significant difference is that a DFU usually comes with multiple pathologies, which, in addition to infection, include neuropathy and peripheral vascular disease. DFUs do not heal quickly and often require vascular surgeons working closely with radiologists, orthopaedic surgeons to correct any deformity and a microbiology unit to manage infection,” says Rashid.
 
What are diabetic foot ulcers?
 
Why does therapy for diabetic foot ulcers complications require a special center?

Rashid also explains that different therapies are used to heal DFUs. “If the patient has peripheral artery disease (ischaemia) then this has to be treated first with an angioplasty or a bypass or both to improve blood circulation into the foot. Once this is achieved, the ulcer is debrided and dressed. There are different dressings, which include negative pressure dressing, which sucks the blood into the tissues and thereby promotes healing. Sometimes skin graphs are necessary to get the tissue to heal faster. This can be done as a day surgery using local anaesthetic,” says Rashid.
 

How do diabetic foot ulcers heal?

Prevention of DFUs
 
Given the severity of DFUs and their vast and rapidly increasing burden on individuals with diabetes and healthcare systems, increasing attention is being devoted to prevention,  which involves adequate glycaemic control and modification of risk factors. While education is an obligation of healthcare professionals, it is crucial that people living with diabetes themselves increase their awareness and understanding of the condition and integrate regular feet examination and care into their daily lives.  In the video below, Roni Sharvanu Saha, Consultant in Acute Medicine, Diabetes and Endocrinology, St George’s Hospital, London, suggests that, “We’re getting better at understanding why DFUs occur, and better at examining peoples’ feet. In England, if you have diabetes you are entitled to a clinical examination of your feet at least twice a year. Checks include whether you have any minor abrasions, or whether you can distinguish hot and cold water with your feet, and  signs that you might have problems with your circulation and nervous system. Ensuring that people living with diabetes receive regular checks means that if you have reduced or poor circulation, you’re referred to the correct specialty team in order to protect you from developing DFUs. Prevention is better that cure. If we can get better at examining feet, outcomes will improve. If diabetes is not controlled complications will occur”.
 
 
New therapies and amniotic membrane
 
With the well-being of millions of people living with diabetes at stake, there is a pressing need for therapies that bring DFUs to closure as quickly as possible. The current standard of care (SOC) regimen for DFUs involves maintaining a moist wound environment, debriding nonviable tissue, relieving pressure with an offloading boot and preventing or managing wound infection. Even with a good SOC, DFUs are notoriously slow to close, creating a demand for new and innovative medicines and techniques to enhance closure. Increasingly, there are advanced therapies to facilitate healing DFUs when traditional approaches fail.
 
An example of a relatively new product to help close DFUs is human amniotic membrane.  Amniotic membrane has been used for wound healing purposes since the early 20th century, but it represents a relatively recent and promising advanced therapy to accelerate healing in DFUs. Amniotic membrane is derived from the human placental sac that supports the foetus by forming the inner lining of the amniotic cavity. Functions of amniotic membrane include the exchange of water-soluble molecules and the production of cytokines and growth factors  to facilitate the development of the foetes. The anatomic makeup of amniotic membrane dictates its functionality, and a significant characteristic is its ability to produce a wide variety of regenerative growth factors that facilitate foetal development. These growth factors, in combination with various other cytokines, have substantial potential benefits in wound healing, which include creating a structural scaffold for tissue proliferation, modulating the immune response, reducing inflammation, stimulating angiogenesis and facilitating tissue re-modelling.
 
Two studies of human amniotic membrane products used in wound healing

Two small but significant prospective cohort studies on the effectiveness of human amniotic tissue to treat DFUs were reported in the journal Wounds. One in the March 2016 edition and another in the November 2017 edition. The first is a prospective, randomized, multicentre, controlled study and the second a retrospective cohort study of 20 patients. In both studies amniotic membrane is used in combination with SOC, including debridement, well-controlled offloading, management of bacterial burden, and adequate perfusion.
 
Both studies suggested that the use of amniotic membrane is more likely to: (i) lead to complete wound closure, (ii) accelerate the rate of wound closure, and (iii) present no additional safety risks when compared to SOC alone in the treatment of DFUs. The first study demonstrated a statistically significant advantage of an amniotic membrane as compared to SOC in facilitating closure of chronic DFUs. 45% of participants achieved complete wound closure, while 0% of SOC participants alone achieved complete wound closure within 6 weeks. Further, there appears to be no increased rate of adverse events associated with the use of amniotic membrane in these wounds. The second study was a retrospective cohort study using a human amniotic membrane on 20 patients presenting with DFUs and venous leg ulcers. Patients underwent a 2-week ‘run-in’ period with good SOC; and if upon their return the ulcer had closed ≥ 30% in area, the subject was excluded from participation in the study. All wounds were effectively closed in approximately 10 weeks, DFUs in 12 weeks and venous leg ulcers in 9 weeks, and no adverse events were noted, suggesting that the therapy using human amniotic membrane is safe.
 
Discussion
 
The most significant limitation of both studies is their small sample size, which decreases the generalizability of their findings. Notwithstanding, the studies suggest that amniotic tissue products are efficacious options for DFUs when used in conjunction with the current SOC, which includes aggressive sharp debridement, adequate offloading and the application of sterile dressings. Further, amniotic membrane, like most biologic tissue products, requires significant processing and therefore its cost is relatively high: on average between US$500 to US$1,000 per application. Notwithstanding, these costs are significantly less than the average annual therapy cost of US$28,000 per patient for SOC for a DFU. And therefore, using amniotic tissue in the therapy for DFUs could result in significant savings for healthcare systems. Tissue storage as well as the time and skill required to apply amniotic membranes also represent challenges inherent to these products.
 
Takeaways
 
Millions of people are living with diabetes, which, if not managed appropriately can lead to life-changing complications. A DFU is one such complication, which often starts with a minor abrasion on your ankle or toe that you do not feel and therefore tend not to perceive to be important, until that is, it quickly escalates into a chronic wound that does not heal and eventually leads to a lower limb amputation. In most wealthy nations, health providers are aware of the dangers of DFUs and have set up multi-disciplinary diabetic foot clinics to treat and manage the condition. However, access to such clinics is patchy and the prevalence of DFUs continues to increase, and the eye-watering costs of treating and managing DFUs continue to escalate. In recent years, the therapy for DFUs has been improved by technological advances. We describe one of these: the use of amniotic tissue in conjunction with standard of care protocols. Recent research findings suggest that the use of amniotic tissue holds out the possibility not only of significant therapeutic benefits, but also of substantial cost savings for healthcare systems. Notwithstanding, perhaps the most efficacious therapy for DFUs is prevention. This means investing in effective education and awareness programs, good glycaemic control and appropriate footwear; encouraging people living with diabetes to participate in regular foot examinations and screening for peripheral neuropathy and peripheral arterial disease, and insisting that early telltale signs of foot wounds, no matter how minor, should be immediately referred to a specialist clinic.
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4 years, 8 months ago

Ramadan Mubarak 2020

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The HealthPad team extends Ramadan Mubarak to all our friends, family members and colleagues who are participating in the Holy Month of Ramadan. We very much would like to share with you a short video by DrSufyan Hussain, Consultant Physician in Diabetes and Endocrinology at Guy's and St Thomas' NHS Foundation Trust, London, UK, which we made to specifically help those who are living with diabetes and fasting.
During these unprecedented challenging times caused by the coronavirus CoVID-19 pandemic, we trust that you all stay safe and well and let the spirit of Ramadan remain in your hearts and light up your souls from within.
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7 years, 7 months ago

A new therapeutic approach to pre-diabetes

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Diabetes
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bariatric surgery
commentary
diabetes control
diabetes education
diabetes management
diabetes medicines
gut-brain axis
healthy lifestyle
pre-diabetes
type 2 Diabetes
 
  • A recent study suggests that a drug combined with dietary and lifestyle changes can prevent those with pre-diabetes from progressing to full blown type-2 diabetes (T2DM)
  • T2DM kills millions and cost billions
  • 35% of adults in the UK, and 50% in the US now have prediabetes
  • The UK has launched the world’s first nationwide diabetes prevention program called Healthier You based on personal education and training
  • Prevalence rates of T2DM are still rising 
  • Research on the gut-brain axis suggests that drugs have a role to play in preventing T2DM
  • An optimum strategy might consist of appropriate drug therapy combined with appropriate education, which leverages ubiquitous 21st century communications infrastructures
  
A new therapeutic approach to pre-diabetes
 
Findings of an international clinical study published in The Lancet in 2017 suggest that 3.0mg of the drug liraglutide, may reduce diabetes risk by 80% in individuals with pre-diabetes and obesity, and thereby significantly contribute to the prevention of type-2 diabetes (T2DM). The study investigated whether 3.0mg of liraglutide would delay the onset of T2DM safely in people with pre-diabetes.
 
Liraglutide is the active solution in a drug marketed as Victoza, which obtained FDA approval in 2010.  Victoza is available in 6 mg/ml pre‑filled pens, and is used as an adjunct to diet and exercise to improve glycaemic control in adults with T2DM. Victoza is used also as an add-on to other diabetes medicines, when these, together with exercise and diet, are not providing adequate control of blood glucose.
  
Pre-diabetes

Pre-diabetes is a condition that develops when your blood sugar levels are at the very high end of the normal range, but not quite high enough for a diagnosis of T2DM.  Risk factors include age, weight and ethnicity. People of South Asian origin are up to six times more likely to develop pre-diabetes as a genetic susceptibility means they start to develop insulin resistance at a much lower Body Mass Index (BMI). With pre-diabetes your body begins to have trouble using the hormone insulin, which is necessary to transport glucose, which your body uses for energy, into your cells via the bloodstream. Pre-diabetes means that your body either does not make enough insulin or it does not use it well (insulin resistance). If you do not have enough insulin or if you are insulin resistant, you can build up too much glucose in your blood, leading to higher-than-normal blood glucose level and perhaps pre-diabetes. Blood glucose is measured using a test called HbA1c, which provides a picture of your blood sugar levels over the past two to three months. It counts the number of glucose molecules stuck to the red blood cells, which reveals how much sugar you have carried in your blood over the two to three month lifespan of the red blood cell. If your blood sugar is between 5.7 to 6.4%, this is called pre-diabetes (6.5 is officially diabetes). Dr Roni Sharvanu Saha, a consultant in acute medicine, diabetes and endocrinology at St George's Hospital, London describes pre-diabetes:
 

Prevalence and cost 
 
It is estimated that 35% of adults in the UK, and 50% in the US now have pre-diabetes. Around 5-10% of these will progress to "full-blown" T2DM in any given year. Because there are no obvious symptoms for pre-diabetes the overwhelming majority of people with the condition do not know they have it, and are not aware of the long-term risks to their health, which include T2DM and its complications: heart attack, stroke, kidney failure, blindness and lower limb amputation. Over the past decade, the prevalence of T2DM has increased by almost two-thirds, and is now one of the world’s most common long-term health conditions.
 
An estimated £14bn is spent each year on treating diabetes and its complications in the UK. Treating obesity-linked illnesses costs £10bn a year. The annual medical cost of treating diabetes in the US is about US$176bn, and the cost of diabetes in reduced productivity is some US$69bn each year.
 
The gut-brain axis

The study published in The Lancet was led by John Wilding, Professor of Medicine, University of Liverpool, and is a continuation of work he started in 1996 when part of a team at Hammersmith Hospital in London, which first showed that the hormone GLP-1, on which liraglutide is based, was involved in the control of food intake.
 
Over the past two decades scientists have increased their understanding of the two-way communications between the gut and the brain, not only through nerve connections between the organs, but also through biochemical signals, such as hormones that circulate in the body. Dr Sufyan Hussain, Specialist Registrar and Honorary Clinical Lecturer in Diabetes, Endocrinology and Metabolism at Imperial College London, describes the gut-brain axis.
 
 
Targeting gut-brain pathways

An increasing number of different gut microbial species are now postulated to regulate brain function in health and disease. The westernized diet, which is high in saturated fats, red meats, and carbohydrates, and low in fresh fruits and vegetables, whole grains, seafood, and poultry, is hypothesized to be the cause of high obesity levels in many countries. For example, 63% and 69% of adults in the UK and US respectively are either overweight or obese, and therefore at risk of T2DM. Experimental and epidemiological evidence suggest that the gut microbiota is responsible for significant immunologic, neuronal, and endocrine changes that lead to obesity. The gut–brain axis influences obesity, and researchers such as Wilding have targeted communication pathways between the nervous system and the digestive system in an attempt to treat metabolic disorders. 
 
Bariatric surgery and diabetes

A previous HealthPad Commentary describes how bariatric surgery is associated with gut-brain signals, which promote the remission of diabetes in patients. Many of the mechanisms that underlie how bariatric surgery produces metabolic benefits remain unclear, but researchers do know that such surgical procedures elevate levels of the hormones peptide YY (PYY), and glucagon-like peptide-1 (GLP-1) that help to reduce appetite and have effects on the central nervous system.
 
Liraglutide

Liraglutide is a GLP-1 receptor agonist, which interacts with the part of the brain that controls appetite and energy intake. The drug slows food leaving the stomach, helps prevent your liver from making too much sugar, and helps the pancreas to produce more insulin when your blood sugar levels are high. The most common side effects with liraglutide are nausea and diarrhoea.
 
The clinical study

The three-year study followed 2,254 adults with pre-diabetes at 191 research sites in 27 countries worldwide. Participants were randomly allocated to either liraglutide or a placebo delivered by injection under the skin once daily for 160 weeks. Participants in the study were also placed on a reduced calorie diet and advised to increase their physical activity. The study showed that three years of continuous treatment with once-daily 3.0mg of liraglutide, in combination with diet and increased physical activity, reduces the risk of developing T2DM by 80% and results in greater sustained weight loss compared to the placebo.

"On the basis of our findings, liraglutide 3.0mg can provide us with a new therapeutic approach for patients with obesity and pre-diabetes to substantially reduce their risk of developing type 2 diabetes and its related complications . . . . It is very exciting to see a laboratory observation translated into a medicine that has the potential to help so many people, even though it has taken over 20 years,” says Wilding.
 
World’s first nationwide diabetes prevention program

NHS England, Public Health England and Diabetes UK launched the world’s first nationwide diabetes prevention strategy, Healthier You, in 2016. It provides personal coaches to educate people at risk of T2DM in healthy eating and lifestyle, and personal trainers to provide bespoke physical exercise programs that are expected to help people lose weight. By 2020 Healthier You expects to be rolled out to the whole country with 100,000 referrals available each year after that.
 
Extrapolating from previous studies

International clinical studies have shown evidence that lifestyle interventions such as those used in Healthier You can prevent or delay the onset of T2DM. However, the validity of generalizing the results of previous prevention studies is uncertain. Interventions that work in some societies may not work in others, because social, economic, and cultural forces influence diet and exercise. The UK’s Public Accounts Committee has expressed doubts about the way Healthier You is setting about its task, and has warned that, "By itself, it will not be enough to stem the rising number of people with diabetes".
 
Failure of the diabetes establishment and the Public Accounts Committee

Healthier You is a slow, labor-intensive and expensive program, which is unlikely to have more than a relatively small impact.Let us explain. Assume that after 2020 Healthier You obtains its projected annual 100,000 referrals, and that they all successfully reduce their blood glucose levels with diet and exercise. Also assume that the prevalence of pre-diabetes in the UK does not increase, (which is not the case) then Healthier You will take more than 110 years to counsel the estimated 11.5m people in the UK with pre-diabetes: which is long after most people with pre-diabetes would have died from natural causes.
 
21st century communications

Successfully changing the diets and lifestyles of the 11.5m people in the UK believed to have pre-diabetes, and slowing their progression to T2DM will require 21st century technologies. Inexpensive and ubiquitous healthcare technologies used to educate and support diets and lifestyles abound. Increasingly people are demanding devices that track weight, blood pressure, daily exercise and diet. From apps to wearable’s, healthcare technology lets people feel in control of their health, while also providing health professionals with more patient data than ever before. With more than 100,000 healthcare apps, rapid growth in wearables, and 75% of the UK population now owning a smartphone, digital technology is well positioned to significantly improve healthcare education and management.
 
Takeaways

Has Healthier You missed the elephant in the room? Wilding’s study suggests that an exercise and diet program needs to be complemented with a sustained program of appropriate drugs if we are to reduce those with pre-diabetes from progressing to full blown T2DM. Further, simple arithmetic suggests that the education element of such a strategy about diet and lifestyle should leverage ubiquitous 21st century communications infrastructures if they are to be efficacious.
 
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8 years, 4 months ago

Diabetes and cardiovascular disease

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diabetes complications
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insulin therapy
type 1 diabetes
type 2 diabetes
  • Diabetes is closely associated with cardiovascular disease (CVD)
  • Heart attack and stroke cause premature death in people with diabetes
  • People living with type-2 diabetes can prevent or slow the onset of CVD
  • Lower CVD risk by exercising, eating healthily, controlling your weight, and giving up smoking
 
Diabetes and cardiovascular disease

Diabetes is treatable, but people with diabetes have a greater risk of developing cardiovascular disease (CVD) than people who do not have diabetes. Indeed, adults with diabetes are two to four times more likely to develop heart disease or a stroke than adults without diabetes. The reason for this is because people with diabetes, particularly type-2 diabetes (T2DM), may have specific conditions that contribute to their risk of developing CVD. These include high blood pressure, abnormal cholesterol and high triglycerides, obesity, physical inactivity, high and poorly controlled blood sugars, and smoking.

Keeping your diabetes under control by managing the risk factors will help protect your heart health. Most people with T2DM are prone to accelerated atherosclerosis, and could ultimately die of cardiovascular disease (CVD). Many will die prematurely. Overall, the incidence of CVD is declining, but for people with diabetes it is increasing.

Much of diabetes care is the prevention of CVD by modifying blood pressure, blood glucose, and lipids, and this involves both medical therapies, and lifestyle changes, as Dr Roni Sharvanu Saha, Consultant in Acute Medicine, Diabetes and Endocrinology at St George's Hospital, London, explains:
 
 
Blood pressure and glycaemic control

Blood pressure and glycaemic control often require multiple drug therapies, which are less likely to produce side effects than a signal agent. Glycaemic control is important for controlling both macro and micro vascular disease. The former includes myocardial infarction and stroke; the prime causes of excess mortality in diabetes. Preventing microvascular complications is important to reduce the risk of retinopathy, and nephropathy. 
 
Insulin therapy

Increasing numbers of people with T2DM are using insulin therapy to achieve tight glycaemic control. The challenge is to reconcile reduced HbA1c with the risk of hypoglycaemia. There is an important debate between tight and adequate glycaemic control.  A 2014 Australian study reported in the New England Journal of Medicine suggests that there is no evidence that tight glucose control leads to long-term benefits with respect to mortality or macrovascular events. 
 
Antihypertensive medication
 
The majority of people with T2DM whose blood pressure is not within the 140/80-range will require antihypertensive medication, which is usually an angiotensin converting enzyme (ACE) inhibitor. If the target blood pressure is not achieved, a calcium channel blocker or diuretic can be taken in combination. ACE inhibitors are inappropriate for pregnant women, and may be a less effective alternative for those of Afro Caribbean descent where a calcium channel blocker may be more effective.
 
Lipid lowering
 
Lipids are fat-like substances in the blood, and cholesterol is one type of lipid. In order for lipids to travel in the blood they must be coated with protein: lipoprotein. Excess cholesterol is detected by measuring lipoprotein. High cholesterol is a major controllable risk factor for CVD. As blood cholesterol rises, so does the risk of CVD. Recommended targets for cholesterol lowering in diabetes are total cholesterol bad cholesterol,

People with high cholesterol may be prescribed a statin, which is a group of medications that can lower bad cholesterol, and thereby reduce the risk of CVD, as Professor Olaf Wendler,Consultant Cardiothoracic Surgeon at King’s College Hospital and  Professor of Cardiac Surgery at King’s College London explains :
 

However, high cholesterol is just one risk, and statins are usually offered to people who have been diagnosed with a form of CVD, or whose personal and family medical histories suggest they are likely to develop CVD at some point over the next 10 years.
 
Side effects

Statins are tablets to be taken at the same time once a day, and in most cases, will need to continue for life, as stopping the medication will cause high cholesterol levels to return within a few weeks.
 
There are significant risks associated with mixing statins and grapefruit, which include muscle breakdown, liver damage and kidney failure. Statins also carry other risks, such as digestive problems, increased blood sugar and neurological side effects, including confusion and memory loss.
 
Lifestyle

In addition to drugs, people with T2DM experiencing hypertension, and high cholesterol are encouraged to eat a healthy diet low in saturated fats, exercise regularly, stop smoking, and reduce salt and alcohol. Smoking is particularly harmful for people with diabetes since it increases the risk of macrovascular disease and microvascular complications.
 
Takeaways

Diabetes is closely associated with CVD. Heart attack and stroke are the major causes of premature death in people with diabetes. With the rising prevalence of diabetes, especially in developed countries, the double jeopardy of diabetes and CVD is set to result in an explosion unless preventive action is taken.
 
Managing T2DM involves a combination of drugs and lifestyle. Self-management is enhanced by increased knowledge of the condition. People living with T2DM can either prevent or slow the onset of CVD by increasing their physical exercise, eating a healthy balanced diet, controlling their weight, and giving up smoking.
 
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10 months ago

How to prevent heart disease

New York Cardiac Diagnostic Center
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Heart disease
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heart attack specialist
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heart attack treatment
heart failure treatment
how to prevent heart disease
stroke treatment

The leading killers in the United States are heart attacks and strokes. Annually, around 860,000 Americans die from heart disease or another untreated cardiovascular condition. The most preventable precursors to a heart attack are high blood pressure, bad nutrition habits, high cholesterol, smoking, limited or no physical exercise, obesity and type 2 diabetes.

Heart attacks and strokes are the leading causes of death in the United States. Every year, around 860,000 Americans die as a result of heart disease or another untreated cardiovascular condition. High blood pressure, poor nutrition, high cholesterol, smoking, little or
best cardiovascular specialist in NYC no physical activity, obesity, and type 2 diabetes are the most preventable precursors to a heart attack.

The onset of a heart attack can be sudden and severe, but most begin as a gradually increasing pain in your chest. In the United States, a heart attack occurs about once every 40 seconds. Strenuous activities like sports, heavy labor, and other physical activities are often credited as an inciting cause of a heart attack. But the real causes are typically longstanding health issues that are varied and complex.

Read more: https://newyorkcardiac.com/heart-attack 

New York Cardiac Diagnostic Center
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11 years, 10 months ago

Whose age is it anyway?

HealthPad
Directory:
Medicine
Tags:
ageing population
commentary
healthcare policy

“If I’d known I was going to live this long I would have taken better care of myself.” Memorable words from Eubie Blake, the American jazz composer, lyricist and pianist who died in 1983 at the age of 96. Today, people do take better care of themselves. Examples of people who do, include rock legends Mick Jagger and Paul McCartney, the badboys of the 1960s who became the goodboys of the 1990s. Now, at 70 and 69 respectively, they continue to work, support worthy causes and enjoy a good quality of life.

Over the past 50 years, the number of people over 65 in the developed world has tripled and is projected to triple again by 2050. The UK’s Office of National Statistics forecasts that a third of babies born in 2012 will live to 100. “Age is uninteresting,” said Groucho Marx, “All you have to do is to live long enough.” Age, however has become interesting as it is an unavoidable part of the human condition and a significant challenge for nations where millions will be retiring with a third of their lives still ahead of them. They will no longer be productive, but will be in need of healthcare. Healthcare systems have been slow to adjust to the new realities of aging populations and the financial costs of treating the elderly.

One way for nations to manage retirement and aging was suggested by Euripides in 500BC. “I hate men,” he said, “who would prolong their lives by foods and charms of magic art, preventing nature’s course to keep off death. They ought, when they no longer serve the land, to quit this life and clear the way for youth.” Euripides’ sentiment resonates today. In advanced industrial economies there is a relatively low tolerance of elderly people. This is manifest in the number of offences against elderly vulnerable patients, which involves neglect and physical violence. In his 2013 Report into the UK's Mid-Staffordshire NHS Foundation Trust, where hundreds of patients had died as a result of inadequate care, Robert Francis said that between 2005 and 2009 patients were subject to, “appalling and unnecessary suffering”. In June 2012, at a conference in London’s Royal Society of Medicine, Professor Patrick Pullicino claimed that each year UK National Health doctors prematurely end the lives of about 130,000 elderly hospital patients because they are difficult to manage and to free up beds for younger patients.

According to a UN Report presented at the World Assembly on Aging in 2002, population aging is an unprecedented global phenomenon. The 21st century will witness more rapid aging than did the 20th century and countries that started the process later will have less time to adjust. There will be no return to the young populations of previous generations and aging populations will have profound implications for healthcare.

Moralists argue that healthcare is a human right and all people should be treated similarly unless there are sound moral reasons not to do so. But, who pays? Daniel Callahan, a contemporary philosopher widely recognized for his innovative studies in biomedical ethics has an answer. Invoking Euripides he argues that age should be a limiting factor in decisions to allocate certain kinds of health services to the elderly. The demographic shift, says Callahan, increases competition for scarce healthcare resources and therefore healthcare should be rationed. Life extending care for the over 70s should be replaced with less expensive pain relieving treatment. Opponents of rationing suggest that wealthy governments should reduce their defense spending and increase their commitment to healthcare and enact reforms to cut costs and improve the efficiency of healthcare systems.

Callahan, however, has little faith in political leaders to deliver cost cutting strategies and argues that calls to cut healthcare waste and inefficiency have been made for decades with no effect. This is definitely the case in the UK where subsequent governments have failed to reconcile escalating costs of healthcare with maintaining and improving the quality of care for the elderly. According to Callahan, “Our whole health care system is based on a witch’s brew of sacrosanct doctor-patient autonomy, a fear of threats to innovation, corporate and (sometimes) physician profit-making, and a belief that, because life is of infinite value, it is morally obnoxious to put a price tag on it.”

Some age related incurable diseases that affect mostly older people in wealthy countries have contributed to the ghettoizing of age. One such disease is Parkinson’s, a progressive degenerative neurological movement disorder, which affects between six and 10 million people worldwide. In the US, the combined direct and indirect costs of Parkinson’s disease is estimated to be nearly US$25 billion per year. Medication costs for an individual person with Parkinson’s is on average US$2,500 a year and therapeutic surgery, such as deep brain stimulation, can cost up to US$100,000 dollars per patient.

However, not all age related diseases are like Parkinson’s. Indeed, it is not altogether true that old age corresponds to debilitating diseases and hikes in healthcare costs. Indeed, healthy years among the elderly are increasing and the spike in health costs tend to be in the last two years of life, regardless whether a person is 99 or nine. Rather than viewing the elderly as a burden and assessing them by their chronological age, it might be more appropriate to view them as assets and assess them by their number of healthy years. Healthy years are not necessarily years without illness, but years in which people manage whatever medical conditions they might have. A good example of this is Dame Maggie Smith, the English film, stage and television actress, who at the age of 78 has recently won a Golden Globe Award for her role as the Dowager Countess of Grantham in the television series Downton Abbey.


Longevity is one of the greatest successes of 20th century medical science and nutrition, but its challenges include the dearth of health workers with geriatric skills, the prevention of physical disabilities and the extension of healthy years. Recent studies suggest that healthy aging is possible and chronic non communicable illnesses such as heart disease, diabetes and dementia, may be delayed or prevented by certain lifestyle choices. Notwithstanding, currently there are millions of elderly people who have not taken good care of themselves and require specialist geriatric care.

In the US there is a monetary disincentive for doctors to specialise in geriatrics since geriatricians earn significantly less per year than more mainstream specialists. Further, only 11 of the 145 US medical schools have fully fledged geriatric departments. In 2010 the US federal budget allocated $11 million to fund geriatric education. Interestingly, today a substantial amount of geriatric care in wealthy countries is undertaken by health professionals trained in poorer countries. This raises ethical questions about rich countries encouraging the immigration of health workers from countries that lack them and the responsibilities of migrant health professionals to countries of their origin. Although geriatricians in the UK are well compensated, the British Geriatric Society reports that the number of geriatricians is not keeping pace with the needs of geriatric care.

According to the OECD between 10% and 20% of populations in developed economies require long term care and costs between 1% and 2% of GDP and these costs are projected to increase. The costs of long term care are skewed because a significant proportion of elderly care is carried out by informal, unpaid carers who are often family members. For example, in the UK there are 1.5 million official carers and about 5 million unpaid carers. In the developing world the situation is more extreme and some 60% of people over the age of 60 live with their children or grandchildren. While familial care may yield significant benefits, it is not a long term solution because as developing economies become more westernized, their family structures become more nuclear and less able to provide the support and care that they do now.

According to the first noble truth of Buddhism, life is painful and involves suffering. For a significant proportion of elderly people this is certainly the case, but it need not be. On an individual level, living longer must be welcome, but more generally, the greying of populations is perceived in terms of increased costs and pressure on overstretched healthcare systems, rather than freeing-up valuable resources that may contribute to society. Although elderly people tend to have long term medical conditions, increasingly they are successfully managed to allow a good quality of life. Old age is not a disease. Elderly people are a valuable resource of intellectual capital and knowhow, which nations cannot afford to waste. Unlocking this reservoir of grey-knowledge is important for the future wealth of nations. Let us hope nations have something better to offer their elderly than to call on them to do as Captain Oates did on the 16th March 1912. On his return from the South Pole, Oates, convinced that his ill health compromised his comrades, walked from his tent into a blizzard saying, "I am just going outside and may be some time.” He was never seen again.

Whose age is it anyway?

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8 years, 1 month ago

Weight loss surgery to treat T2DM

HealthPad
Directory:
Weight Management
Tags:
bariatric surgery
commentary
diabesity
diabetes control
obesity
stomach reduction
T2DM
type 2 diabetes
weight loss surgery
 
  • Obesity is one of the most serious global public health challenges of the 21st century and a major cause of type-2 diabetes (T2DM), a life-threatening illness, which costs billions
  • 60% of adults in the UK are either overweight or obese, 74% in the US
  • Low calorie diets and exercise are difficult to sustain and therefore tend to fail as treatment options 
  • Conventional treatments for T2DM have failed to dent the vast and escalating burden of the condition, so interest is increasing in alternative treatment options
  • Bariatric (stomach reduction) surgery is a therapy for obesity, which has been shown to “cure” T2DM
  • In 2016, 45 international health organizations called for bariatric surgery as a treatment for T2DM
  • Is bariatric surgery the biggest step forward in T2DM treatment in 100 years?
 

Weight loss surgery to treat T2DM


It is five minutes to midnight for healthcare systems struggling in vein to reduce the vast and escalating burden of type-2 diabetes (T2DM). Doing more of the same is no longer an option. Given the lack of alternatives, experts are calling for an increase in bariatric surgery because it has been shown to “cure” T2DM.
 
Bariatric surgery not only reduces weight, it also improves glycemic control by a combination of enforced caloric restriction, enhanced insulin sensitivity, and increased insulin secretion with a consequent reduction in the symptoms of T2DM.
 
In the video below Kenneth D’Cruz, Senior Consultant Gastroenterological Surgeon at Narayana Health, India describes bariatric surgery, which refers to a range of procedures including gastric bypass, gastric sleeve, gastric band, and gastric balloon. Such procedures are often performed to limit the amount of food that an individual can consume, and are mainly used to treat those with a body mass index (BMI) of above 40, and in some cases where BMI is between 30 and 40, if the patient has additional health problems such as T2DM.
 
 
Epidemiology of obesity

Overweight and obesity are principal risk factors of T2DM. In the UK, the number of people classified as obese has doubled over the past 20 years and continues to rise. According to data from the 2014 Health Survey for England, 24% of adults in England are obese and a further 36% are overweight. In 2015, there were 440,288 admissions to England's hospitals for which obesity was the main reason or a secondary factor.
 
Data from the National Child Measurement Programme (NCMP), suggest 10% of children in the UK are obese by the time they start primary school, and 25% are so by the time they finish. 6% of people in the UK are living with diabetes of which 90% have T2DM. Over the past decade the incidence rate of T2DM has increased by 65%.
 
The situation is similar in the US, where 36% of adults are obese, and 6.3% have extreme obesity. Almost 74% of adults are considered either overweight or obese. Over the past 30 years, childhood obesity has more than doubled, and it has quadrupled in adolescents. The percentage of children who were obese increased from 7% in 1980 to nearly 18% in 2012. 9.3% of people in the US are living with diabetes.
 
The World Health Organization warns that obesity is, “one of the most serious global public health challenges of the 21st century”.
 
Causes of obesity

There are many complex behavioural and societal factors that combine to contribute to the causes of obesity. At its simplest, the body needs a certain amount of energy (calories) from food to keep up basic life functions. When people consume more calories than they burn, their energy balance tips toward weight gain, excess weight, and obesity. In the videos below Mohammed Hankir, Department of Medicine, University of Leipzig, Germany, describes what causes obesity, and the relationship between obesity and T2DM:
 
What are the causes of obesity?
 
What is the relationship between obesity and type-2 diabetes?
 
The cost of diabesity

Obesity costs the UK £47bn every year. The medical care costs alone for obesity in the US are estimated to be more than US$147bn. Diabetes treatment and indirect medical costs run to £10.3bn in the UK and US$176bn in the US, representing significant increases over the past five years. The medical costs for an individual with diabetes are typically 2.5 times higher than for someone without the disease. As prevalence of obesity increases these costs will rapidly rise.
 
T2DM prevention and treatment

NHS England, Public Health England and Diabetes UK’s National Diabetes Prevention Program is based upon diet and exercise-induced weight loss, which sometimes remedies insulin resistance. For obese people dietary and lifestyle therapies have limited short-term and almost non-existent long-term success records. According to Professor John Wilding, Head of the Department of Obesity and Endocrinology at the University of Liverpool, UK; the problem with low calorie diets, “is that most people will lose weight, but most people will also regain much of that weight that has been lost.” The UK’s National Institute of Health and Clinical Excellence (NICE) does not support the routine use of low calorie diets.
 
Once an overweight or obese person has T2DM the stakes change. With the limited success of conventional medical therapies, bariatric surgery has become an increasingly popular treatment in the war against obesity and latterly also for T2DM. The 2014 UK National Bariatric Surgery Registry reported that there is good evidence from randomised controlled studies that surgery is superior to medical therapy in improving diabetes control and metabolic syndrome. Surgery lowers the number of hypoglycaemic medications needed, including some people no longer needing insulin. It also means many people living with T2DM going into remission, and it markedly lowers the incidence of T2DM compared to matched-patients not having surgery.
 
NICE guidelines for bariatric surgery as a therapy for diabesity

Concerned about the rising prevalence of diabesity (obesity and diabetes) and the limited success of conventional strategies, in 2011, the International Diabetes Federation endorsed bariatric surgery as a T2DM treatment for obese people. The Federation’s endorsement is a validation of research and medical experience showing that surgery to reduce food intake can alter the biochemistry of the entire body. It also marked the beginning of a major new assault on diabetes.

In 2014, NICE introduced guidelines for bariatric surgery as a treatment option for obese adults, and suggested that it would greatly help T2DM. Current NICE guidelines state that bariatric surgery should be offered to anyone who is morbidly obese (a BMI of 40 or over), to those with a BMI over 35 if they have another condition, such as T2DM, and to those with a BMI of at least 30 with a recent diagnosis of diabetes.
 
In the UK only about 6,500 people each year have bariatric surgery. This is significantly lower than other European countries, which perform on average about 50,000 stomach reduction surgeries each year. Under the NICE guidelines, up to 2m people would be eligible for free bariatric surgery on the NHS, which would cost the taxpayer £12bn.
 
Biggest breakthrough in diabetes care since the introduction of insulin
 
In 2016 a review written by a group of researchers led by David Cummings, an endocrinologist at the University of Washington set out guidelines for bariatric surgery as a treatment option for diabetes. Francesco Rubino, one of the experts behind the guidelines and professor of metabolic and bariatric surgery at King's College London, said: “This is the closest that we have ever been to a cure for diabetes. It is the most powerful treatment to date.” Other doctors who drew up the guidelines said such changes could amount to the most significant breakthrough in diabetes care since the introduction of insulin in the 1920s.
 
The modern Roux-en-Y gastric bypass

The ‘gold standard’ bariatric surgical procedure is the Roux-en-Y Gastric Bypass, which is the most commonly performed bariatric procedure worldwide, named after a 19th century Swiss surgeon César Roux, who first performed the surgery to reroute the small intestine. The modern version of the procedure involves reducing the stomach to a little pouch, to curb eating and appetite, and then connecting that pouch to a lower section of the intestine. By using less of the intestine, fewer nutrients are absorbed, and the patient loses weight.
 
Until recently it has been poorly understood why, after bariatric surgery, a significant proportion of patients with T2DM leave hospital either needing no insulin, or lower doses, before ever losing any weight. Re-plumbing the GI-tract appears to reprogram the body’s hormones and resets its metabolism.
 
Advances in bariatric surgery

Thirty years ago there was little interest in bariatric surgery, which was risky, and not widely practiced. It involved a large, bloody incision, the prising apart of the heavy, fatty abdominal walls with metal arms, which then had to be held in place while the surgeon carried out procedures deep in the gut. Patient recovery times were long, and the risk of complications high.

By the first decade of the 21st century, when obesity became an epidemic in advanced economies the relationship between bariatric surgery and T2DM was given more attention. The medical device industry developed new surgical tools to facilitate blood free minimally invasive procedures for obese people, but researchers were still struggling to understand why bariatric surgery “cured” diabetes.
 
Understanding why bariatric surgery cures diabetes

One of the scientists to discover why bariatric surgery cures T2DM is Blandine Laferrère, an endocrinologist at the New York Obesity Nutrition Research Center at St. Luke’s. Our gut hormone ghrelin signals to our brain that we are hungry and to start eating. Receptors in out GI tract signal to our brain that we are full and to stop eating. In obese people such signalling malfunctions, and leaves them perpetually hungry. According to Laferrère, “It just happened that the surgeons did this type of surgery for weight loss, and that turned out to have a spectacular effect on the remission of T2DM.”

Further research was undertaken by Laferrère and influenced by Werner Creutzfeldt, a German doctor who published work on gut hormones that increased stimulation of insulin secretion, which he called an “incretin effect”. According to Laferrère, bariatric surgery, rather than actual weight loss, stimulates the incretin effect, which boosts the production of insulin while lowering the symptoms of diabetes. She concluded that the surgery itself triggered the hormone network, which diet-induced weight loss could not provide.
 
Takeaways

Scientists claim that bariatric surgery is the biggest step forward in diabetes treatment in 100 years, and suggest we are no longer talking about the treatment of obesity, but treatment of diabetes.
 
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8 years, 4 months ago

Diabetes and kidney disease

HealthPad
Directory:
Diabetes
Tags:
chronic kidney disease
CKD
commentary
diabetes complications
diabetic kidney disease
kidney damage
renal function
type 1 diabetes
type 2 diabetes
 

  • Diabetic kidney disease is an epidemic
  • People with severe kidney disease often do not realize it as its symptoms are non specific
  • People living with the condition need to become more active in its management
  • GPs often do not recognise diabetic kidney disease and fail to refer patients to specialists
  • Kidney failure is one of the most severe and life-threatening complications of diabetes
  • Kidney damage from diabetes accounts for 35% of people with end stage renal disease
  • Chronic kidney disease  (CKD) is diagnosed through specific blood and urine tests
  • CKD can be treated with medicines and lifestyle changes
  • Management of CKD includes glycaemic control, blood pressure control and smoking cessation

Diabetes and kidney disease

Diabetic kidney disease has become an epidemic; people living with diabetes need to become more active in its management in order to either slow the onset of kidney disease or to stabilize it.
 
It is not easy.
 
People with severe kidney disease often do not realize it. Primary care doctors often do not recognise it, and fail to refer patients to specialists. According to the US Renal Data System, 42% of patients with end-stage renal disease (ESRD) had not seen a kidney specialist or nephrologist prior to beginning therapy.  

Kidney failure is one of the most severe and life-threatening complications of diabetes. About 30% of people with type-1 diabetes, and between 10% and 40% of those with type-2 diabetes eventually will suffer from kidney failure. Over the next decade, it is projected that twice as many people will suffer from diabetes related kidney failure.
 
Silent killer

"There is an explosion of kidney disease, but a lot of doctors are not aware of the strong association with diabetes, cardiovascular disease and hypertension," says Dr Robert Stanton, chief of the kidney and hypertension section at Harvard’s Joslin Diabetes Center. "You can slow down kidney disease, and maybe stabilize it. But if you wait too long, very little can be done," says Stanton.
 
Kidney damage from diabetes (diabetic nephropathy) accounts for 35% of people with ESRD. In 2015 some 35,000 people in the UK required kidney dialysis. In the US, more than 100,000 people are diagnosed with kidney failure each year, and an estimated 31 million people have chronic kidney disease (CKD). In India there are some eight million people suffering from chronic kidney failure. Lloyd Vincent, Senior Consultant Nephrologist at Narayana Hrudayalaya, Bangalore, India, here explains how diabetes control is related to kidney function:
 

 
The only way to find out for sure whether you have CKD is through specific blood and urine tests. Once detected, CKD can be treated with medicines and lifestyle changes. These treatments usually decrease the rate at which CKD worsens, and can prevent additional health problems.
 
Your kidneys and diabetes

Your kidneys perform vital functions such as filtering your blood and stimulating your red blood cell production. Diabetes damages small blood vessels in your body, including those in your kidneys. This means your kidneys cannot clean your blood properly, and wastes cannot be removed from your blood, which means kidney failure. Diabetes may also result in nerve damage, which can cause difficulty in emptying your bladder. The pressure resulting from a full bladder can back-up and injure your kidneys. Also, if urine remains in your bladder for a long time, you can develop an infection from the rapid growth of bacteria in urine, and this can affect your kidneys.
 
Early signs

An early sign of diabetic kidney disease (DKD) is an increased excretion of albumin in the urine. Albumin is present long before usual tests show evidence of kidney disease. Weight gain, high blood pressure, ankle swelling, and the need to use the bathroom more at night are also signs. A person with diabetes should have their blood, urine and blood pressure checked at least once a year. Maintaining control of diabetes can lower the risk of developing severe kidney disease.
 
Late signs

As kidneys fail, blood urea nitrogen (BUN) levels rise, as do levels of creatinine in your blood. Signs of late stage kidney disease include nausea, vomiting, appetite loss, weakness, fatigue, itching, muscle cramps (especially in the legs), and anaemia. Also, a person with diabetes might find they need less insulin, which is because diseased kidneys cause less breakdown of insulin.
 
Takeaways
 
Diabetic kidney disease is essentially a microvascular complication, which triggers a vicious circle by promoting macrovascular processes as well. Early intervention is crucial and prevention encouraged. The most effective strategies include: glycaemic control, blood pressure control, and smoking cessation.
 
 
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8 years, 7 months ago

Will the UK’s diabetes prevention program work?

HealthPad
Directory:
Diabetes
Tags:
commentary
diabetes prevention
diabetes prevention program
healthcare costs
obesity
T2DM
type 2 diabetes
 
  • National diabetes prevention program (DPP) uses 19th century methods
  • 60% of adults in England are either overweight or obese
  • 5m adults in the UK are at risk of developing T2DM
  • T2DM devastates the lives of millions and costs billions to treat
  • NHS to offer personal trainers to obese people at risk of T2DM
  • There is no evidence that exercise alone can reduce obesity
  • Public Accounts Committee warns that the DPP is insufficient
 
Will the UK’s diabetes prevention program work?
 
Should we entrust the UK’s clinical establishment with preventing type-2 diabetes (T2DM)?

In March 2015 a consortium spearheaded by NHS England, Public Health England (PHE) and Diabetes UK (DUK) - the UK’s clinical establishment - launched the Diabetes Prevention Programme (DPP). A year later, it has come up with Healthier You, an evidence-based program which it hopes will make a significant contribution towards preventing the 5m people in England at risk of T2DM from developing the disease.
 
What will Healthier You achieve?
 
Previous Commentaries have warned that diabetes will not be prevented by repeating past failures. Despite the fact that we know how to avoid and treat T2DM, and despite the fact that over the past decade some £110bn have been spent on diabetes care and education, the incidence rate of the condition has increased by a staggering 65% over the same period. And still each year In England, there are more than 22,000 avoidable deaths, from diabetes-related illnesses.
 
Because the size of the English population at risk of T2DM is so vast, and because Healthier You is using a variant of past diabetes education programs that have failed, it seems reasonable to suggest that while the DPP may have some limited success, it will fail to make a significant reduction to the overall burden of obesity, which devastates the lives of millions and costs billions.
 
Obesity and T2DM are global epidemics

Currently, in England alone some five million people are either overweight or obese, and therefore at high risk of developing T2DM. The economic cost of obesity is £6.3bn, and expected to rise to £8.3bn in 2025 and £9.7bn in 2050. However, this only reflects costs to the health service, and not wider economic consequences for society. In England in 2014, pharmacies dispensed just over half a million items for treating obesity with a net ingredient cost of £15.3 million. All of these prescriptions were for Orlistat, which prevents the body from absorbing fat from food.
 
If current obesity trends persist, one in three people in England will be obese by 2034, and 1 in 10 will develop T2DM. T2DM is a leading cause of preventable blindness, and is a major contributor to kidney failure, heart attack, and stroke. Each year about 120,000 people in the UK are newly diagnosed with diabetes, and there are about 22,000 avoidable annual deaths from diabetes-related causes. In addition to the human cost, T2DM treatment currently accounts for almost 9% of the annual NHS budget: about £8.8bn a year.
 
Similar trends can be seen in the US, where 86 million people are either overweight or obese and therefore have a high risk of developing T2DM. One in every three American adults has prediabetes, a condition that arises when blood glucose levels are higher than normal, but not high enough for a diagnosis of diabetes. There are 30 million Americans living with T2DM, resulting in two deaths every five minutes.

Obesity is a global epidemic. A study published in The Lancet in 2016 found that in the past four decades, global obesity has more than tripled among men and doubled among women. The study says that if current trends continue, 18% of men and 21% of women worldwide will be obese by 2025. According to Majid Ezzati, Professor of Global Environmental Health at Imperial College London, and the study's senior author, “We have transitioned [to] a world in which  . . . .more people are obese than underweight”. 

Diabetes is a global epidemic. Over the past 35 years 314m more people, making a total of 412m, are now living with the condition: 8.5% of adults worldwide. In 2012, 1.5m people died as a result of diabetes, and 2.2m additional deaths were caused by higher that optimal blood glucose.
 
In England, the rising prevalence of obesity in adults has led, and will continue to lead, to a rise in the prevalence of T2DM. This is likely to result in increased associated health complications and premature mortality, with people from deprived areas and some minority ethnic groups at particular risk. Modelled projections indicate that, all things being equal, costs to the NHS and wider costs to society associated with overweight, obesity and T2DM will rise dramatically in the next few decades.
 
Roni Sharvanu Saha, Consultant in acute medicine, diabetes and endocrinology at St Georges Hospital NHS Trust, London describes prediabetes:
 

 

DPP in the news
 
The launch of Healthier You triggered headlines such as, “Personal trainers on the NHS in war on diabetes”, which raised eyebrows and attracted criticism. Despite mounting evidence to suggest that physical activity alone cannot reduce obesity, and despite being attacked by the National Audit Office (NAO) and the Public Accounts Committee (PAC), the NHS, PHE and DUK are convinced that their DPP will be successful. Professor Jonathan Valabhji, national clinical director for diabetes and obesity at NHS England, and one of the leaders of the DPP, says, “The growing body of evidence makes us confident that our national diabetes prevention programme will reduce the numbers of those at risk of going on to develop the debilitating disease”. Is Valabhji right?

Despite a year of planning and the optimism of the DPP leaders, the UK’s Public Accounts Committee has expressed serious doubts about the way the DPP is setting about its task, and has warned that, "By itself, this [the program] will not be enough to stem the rising number of people with diabetes".
 
Successful pilot studies
 
Behavioral interventions, which nudge people to adopt and maintain a healthy diet and lifestyle, can significantly reduce the risk of developing T2DM. Over the past year, seven demonstrator sites set up by the DPP in England have been testing innovative diabetes educational programs, and have reported the reduction of at-risk people from developing T2DM. One pilot that offered two exercise classes a week, and classroom sessions on diet and lifestyle, found that 100% of its participants lost weight, with more than half reducing their diabetes risk. Intelligence from these studies has informed Healthier You. Three quarters of England’s 211 clinical commissioning groups (CCGs) have already joined forces with local authorities, and will now work with four designated providers to offer personal care to those at high risk of developing T2DM.
 
The service providers
 
The four service providers are: (i) Momenta, which offers weight management for adults, and is part of the Reed Partnership that has already delivered over £0.6bn of publicly funded UK contracts, (ii) Pulse Healthcare, which is part of the ICS Group, an established healthcare service provider that offers health and wellbeing services to local authorities, CCGs and employers, (iii) Health Exchange, which was launched in 2006 as a local authority partnership to provide healthy living advice to local community groups, and (iv) Ingeus, which has evolved from a small Australian rehabilitation company in 1989 to an international provider of employment, training and support services.
 
US has similar diabetes prevention program
 
Healthier You is similar to a US diabetes prevention program, which was developed to improve the health of people at risk of T2DM through improved nutrition and physical activity.  In 2011, through funding provided by the Affordable Care Act, the Centers for Medicare & Medicaid Services (CMS) awarded the National Council of YMCA America more than $11.8m to enrol eligible Medicare beneficiaries at high risk of developing T2DM in a program that could reduce their risk.
 
Participants in the American program attended weekly meetings with a lifestyle coach who trained them in strategies for long-term dietary change, increased physical activity, and behavior changes to control their weight and reduce their risk of T2DM. After the initial weekly training sessions, participants could attend monthly follow-up meetings to help maintain healthy behaviors.
 
Over the course of 15 months, participants lost about 5% of their body weight, which, if maintained, is enough to substantially reduce their risk of future diabetes. Over 80% of participants attended at least four weekly sessions. When compared with similar people not in the program, Medicare estimated savings to be $2,650 for each participant over the 15-month period, which was more than enough to cover the cost of the program.
 
In 2016, independent experts found that the American program saved money and improved peoples’ health, and recommended its expansion into US Medicare. "This program has been shown to reduce health care costs and help prevent diabetes, and is one that Medicare, employers and private insurers can use to help 86 million Americans live healthier,” says US Health Secretary Sylvia Burwell.
 
The results of the US diabetes prevention program are promising, although there is no recognized evidence to suggest that exercise alone reduces obesity. Further, not enough time has elapsed to assess whether the program permanently changed the behavior of participants, and whether they maintained their initial loss of weight.
  
No evidence to suggest exercise can tackle obesity

Despite Healthier You’s emphasis on personal trainers, there is no evidence to suggest that exercise has a role in tackling obesity. A 2015 British Journal of Sports Medicine editorial suggests that it was time to “bust the myth” about exercise. According to the Mayo Clinic, “Studies have demonstrated no or modest weight loss with exercise alone, and that, an exercise regime is unlikely to result in short-term weight loss”. The benefits of exercise are on insulin sensitivity and aerobic fitness, not weight loss. Exercise is a good way to keep weight off, but a bad way to lose weight. To put it in perspective, exercise burns calories, but substantially less than people often think. For example, 1lb of fat is 3,500 calories, and to burn 1lb of fat you would need to run about 40 miles.
 
19th century methods for a 21st century epidemic

The US experience and the English pilot studies suggest that Healthier You is likely to produce some improvement in the overall situation, but research suggests that this will more likely come from diet rather than exercise. The logistics and scale of the problem are so great that Healthier You is unlikely to have more than a relatively small impact. One-to-one life coaches are expensive, difficult to scale, and costly to administer. Successfully engaging a substantial proportion of the vast and rapidly growing English population at risk of developing T2DM, and nudging them to change their diets and lifestyles will require 21st century technologies. That the DPP has chosen 19th century labour-intensive methods to deal with a 21st century epidemic raises doubts about its efficacy.  Let us explain.
 
Not well planned

Healthier You’s 2016 objective is to identify 22,000 people at high risk of T2DM out of a population of 26m across 27 geographic regions of England, and offer them an intensive personalised course in weight loss, physical activity and diet, comprising at least 13 one-to-one, two-hour sessions, spread over nine months, which is estimated to cost £320 per person, or some £7m each year for the cost of the coaches alone.  

By 2020, the DPP expects to have rolled out Healthier You to the whole country, and each year thereafter expects to recruit 100,000 at-risk people found to have high blood sugar levels. At this rate, it will take 50 years, at a minimum annual cost of some £35.2m, to provide 26 hours of personal coaching for the 5m people at risk of T2DM in England. In addition to the cost, the logistics of effectively delivering and accounting for such a program is a significant challenge. The four designated service providers are expected to join forces with the 211 English CCGs, which are the cornerstone of NHS England, and with several thousand local authorities to deliver each year 2.6m hours of one-to-one personal coaching to 100,000 people at risk of T2DM drawn from an adult population of some 50m, and spread across nearly 60 geographic regions in England. A significant percentage of the beneficiaries will be in full time employment and therefore have time constraints. Another complexity is that each CCG commission’s primary care for an average of 226,000 people, and there are some 8,000 GP practices, which ‘own’ the patient data.

Moreover, the £35.2m annual cost estimate does not include the administrative costs associated with identifying and triaging the 5m at-risk people to recruit annually 100,000 people most at risk who will be offered personal coaching, and monitoring the impact this will have on patient outcomes. It seems reasonable to suppose that Healthier You will be difficult to manage, given that the current NHS primary care infrastructure is at breaking point, with a shrinking pool of overworked and demoralised GPs. It will also be extremely expensive as well as wholly inadequate for the scale of the problem. Recently, Dr Maureen Baker, chair of the Royal College of General Practitioners, said: “Rising patient demand, excess bureaucracy, fewer resources and chronic shortage of GPs [are] resulting in worn-out doctors, some of whom are so fatigued that they can no longer guarantee to provide safe care to patients.”
 
Simple arithmetic
 
Did the leaders of the DPP not only over emphasize the potential impact of exercise on obesity, and their ability to manage the program and underestimate the program's costs; but also get their arithmetic wrong in planning the roll out of Healthier You? The DPP leaders must have known that each year for the past 10 years there have been some 100,000 new diagnoses of T2DM. Even if we assume that: (i) there will be no future increase in the incidence rates of obesity and T2DM, (ii) by 2020 Healthier You will be 100% effective in recruiting its annual target of 100,000 at risk people, (iii) Healthier You will be 100% successful in changing the diets and lifestyles of the 100,000 people it recruits each year, and (iv) the annual death rate from diabetes-related causes will remain constant; the conclusion is unavoidable that although the DPP will be spending a minimum of £35m a year to deploy personal trainers, there will still be millions of overweight and obese people, and the incidence rate of T2DM will still be vast and escalating. The T2DM epidemic will not have been dented.
 
 Accountability
 
The UK’s Secretary of State for Health says, “We will be looking closely at the results of this programme.” Does this mean that its leaders will be accountable? To date, the UK government’s record on making people accountable for diabetes care and education is poor.

An earlier Commentary drew attention to the fact that UK diabetes agencies responsible for spending millions each year on diabetes education and awareness programmes which fail, only report on the distribution of services, rather than on the impact those services have had on patient outcomes, which is the most appropriate way of measuring the Healthier You’s effectiveness.  See, The importance of measuring the impact of diabetes care. 
 
Takeaways
 
What will Healthier You achieve?  Given the success of the English pilot studies and the success of the similar American diabetes prevention program, it seems reasonable to expect Healthier You to produce some improvement in the overall situation. However, the scale of the problem is so vast, its management infrastructure so weak, and the impact of exercise on obesity so little, that Healthier You is unlikely to have more than a relatively small impact. The size of the UK population at risk of T2DM is so great that much more modern and efficient tools are needed to get to grips with the problem and make a real difference. A future Commentary will be devoted to describing some of the technological advances being made to tackle obesity and T2DM.
 
Preventing T2DM is too important to be entrusted to our well-resourced clinical establishment that has failed to dent the large and rapidly rising burden of the condition. Preventing T2DM requires leadership and an efficacious strategy, which in the short term, innovates and leverages the use of mobile technologies to engage millions of at-risk people, and nudge them to become permanently enthusiastic about changing their diets and lifestyles; in the medium term, recruits corporates, educational establishments, restaurants, and faith groups into the overall prevention strategy; and in the long term, promotes changes in our environment so that we are obliged to live healthier lives. 
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