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5 years, 11 months ago

Bridging the gap between medical science and policy to reduce the biggest 21st century healthcare burden

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Bridging the gap between medical science and policy to reduce the biggest 21st century healthcare burden

 
In November 2018 the Mayor on London Sadiq Khan, announced that junk food adverts will be banned on all London transport from February 2019 in an attempt to reduce the “ticking time bomb” of childhood obesity in the city.

London has one of the highest obesity rates in Europe with some 40% of 10 to 11-year olds either overweight or obese, with children from more deprived areas disproportionately affected. Obesity is a common and costly source of type-2 diabetes (T2DM), which is much more aggressive in youngsters and complications of the condition - blindness, amputations, heart disease and kidney failure - can present earlier. What is happening in London and the UK is replicated in varying degrees in cities and nations throughout the world: there is a global epidemic of obesity and T2DM, which together is often referred to as ‘diabesity’.
 
The “good” news is that at the same time Khan announced the advertising ban, the UK’s national news outlets were reporting the product of four decades of scientific research, which suggested that T2DM could be reversed by a liquid diet of 800-calories a day for three months.
 
Although this offers hope for millions of people, an unresolved challenge is whether this simple and cheap therapy will be implemented effectively to significantly dent the burden of diabesity, which arguably is the biggest healthcare challenge of the 21st century.
 
In this Commentary

We describe some of the research behind the news reports about the therapy to reverse T2DM. Although the scientists’ innovative solution of a low-calorie liquid diet has been adopted enthusiastically by some healthcare providers and organizations specifically set up to dent the burden of diabesity, it is questionable whether the gap between science and policy can be bridged. This, we suggest, is because the prevalence of diabesity is growing at a significantly faster rate than the effect of programs to prevent and reduce the condition.
 
Obesity and T2DM

Obesity, which is a significant risk of T2DM, is a complex, multifaced condition, with genetic, behavioural, socioeconomic and environmental origins. Diet and sedentary lifestyles may affect energy balance through complex hormonal and neurological pathways that influence satiety. Also, urbanization, the food environment and the marketing of processed foods are contributory factors to becoming overweight and obese. Notwithstanding, the main driver of weight gain is energy intake exceeding energy expenditure.
 
T2DM is a chronic, progressive metabolic disease, which until recently has been perceived as incurable. Although genetic predisposition partly determines the condition’s onset, being overweight and obese are significant risk factors. Generally accepted clinical guidelines to treat the condition is to reduce glycated haemoglobin (HbA1c) - blood sugar (glucose) - levels. The HbA1c test assesses your average level of blood sugar over the past two to three months. The normal range for HbA1c is 4% to 5.9%. In well-controlled diabetic patients HbA1c levels are less than 6.5% or 48mmol/moll. High levels of HbA1c mean that you are more likely to develop diabetes complications, such as serious problems with your heart, blood vessels, eyes, kidneys, and nerves. T2DM is treated primarily with drugs and generic lifestyle advice, but many patients still develop vascular complications and life expectancy remains up to six years shorter than in people without diabetes. 
 
Obesity

The Organisation for Economic Co-operation and Development’s (OEDC) 2017 Health at a Glance Report warned that obesity in the UK has increased by 92% in the past two decades. Two-thirds of the UK’s adult population are overweight and 27% have a body mass index (BMI) of 30 and above, which is the official definition of obesity. In 2017 there were 0.6m obesity-related hospital admissions in the UK, an 18% increase on the previous year. Each year, obesity cost NHS England in excess of US$10bn in treatment alone.
 
A 2018 World Health Organization (WHO) report suggests that obesity globally has almost tripled since 1975. In 2016, more than 1.9bn adults, 18 years and older, were overweight. Of these over 650m were obese. According to a 2018 WHO report on childhood obesity 41m children under the age of 5 were overweight or obese in 2016 and over 340m children and adolescents aged 5-19 were overweight or obese.
Bad diets
 
Diets in the UK, and in most wealthy advanced industrial economies, tend to have insufficient fruit and vegetables, fibre and oily fish and too much added sugar, salt and saturated fat. Rising consumption of processed food and sugary drinks are significant contributors to the global obesity epidemic. A typical 20-ounce soda contains 15 to 18 teaspoons of sugar and upwards of 240 calories. A 64-ounce cola drink could have up to 700 calories. People who consume such drinks do not feel as full as if they had eaten the same number of calories from solid food and therefore do not compensate by eating less. While healthy diets are challenging for most populations, low income levels and poor education are associated with less healthy diets.

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Weight loss surgery to treat T2DM
T2DM brief epidemiology

Almost 4.6m people in the UK and 30m Americans are living with diabetes:  90% of whom have T2DM. It is estimated that 12.3m people in the UK and some 70m in the US are considered pre-diabetic, which is when you have high blood glucose levels, but not high enough to be diagnosed with diabetes. The first WHO Global report on diabetes published in 2016 suggests that 422m adults (1 in 11) worldwide are living with the condition, which has quadrupled over the past three decades. The International Diabetes Federation (IDF) estimates that this figure will rise to 642m by 2040.  A further challenge is the undiagnosed. A December 2017 paper in Nature Reviews: Endocrinology suggests 46% of all cases of diabetes globally are undiagnosed and therefore at enhanced risk of complications. Until complications develop, most T2DM patients are managed within primary care, which constitutes a significant part of general practice activity. International data suggest that medical costs for people with diabetes are two to threefold greater than the average for people without diabetes.
 
T2DM treated but not cured

The most common therapy for T2DM patients who are overweight is metformin, which is usually prescribed when diet and exercise alone have not been enough to control your blood glucose levels. Metformin reduces the amount of sugar your liver releases into your blood and also makes your body respond better to insulin. Insulin is a hormone produced by your pancreas that allows your body to use sugar from carbohydrates in food that you eat for energy or to store glucose for future use. The hormone helps to keep your blood sugar levels from getting too high (hyperglycaemia) or too low (hypoglycaemia). Metformin does not cure T2DM and does not get rid of your glucose, but simply transfers your excess sugar from your blood to your liver. When your liver rejects your excess sugar, the medicine passes the glucose onto other organs: kidneys, nerves, eyes and heart. Much of your excess sugar gets turned into fat and hence you become overweight or obese. T2DM has long been understood to progress despite glucose-lowering therapy, with 50% of patients requiring insulin therapy within 10 years. This seemingly inexorable deterioration in control has been interpreted to mean that T2DM is treatable but not curable. Research briefly described in this Commentary suggests that T2DM can be beaten into ‘remission’, but it requires losing a lot of weight and keeping it off.
 
Reversing T2DM

Over the past decade a series of studies, led by Roy Taylor, Professor of Medicine and Metabolism at the University of Newcastle, England and colleagues from Glasgow University have explored the notion that losing weight could be the solution for controlling T2DM and lowering the risk of debilitating and costly complications.
 
Findings of a study in the December 2017 edition of the  Lancet, suggested that nearly 50% of people living with T2DM who had participated in a low-calorie liquid diet of about 800 calories a day for three to five months had lost weight and had reverted to a non-T2DM state. The study was comprised of 298 adults between 20 and 65 who had been diagnosed with T2DM within the past six years drawn from 49 primary care practices in Scotland and Tyneside in England. Half of the practices put their patients on the low-calorie diet, while the rest were in a control group and received the standard of care of anti-diabetic medicines to manage their blood glucose levels. About 46% of 149 individuals with T2DM who followed a weight loss regimen achieved ‘remission’, which the study defined as a HbA1c of less than 6.5% after one year. Only 4% of the control group managed to achieve ‘remission’. ‘Remission’ rather than ‘cure’ was used to describe the reversal of T2DM because if patients put weight back on, they may become diabetic again. Results improved according to the amount of weight lost: 86% of those who lost more than 33 pounds attained remission, while 57% of those who lost 22 to 33 pounds reached that goal.
 
Another paper by Taylor and his colleagues published in the October 2018 edition of Cell Metabolism, examined reasons why substantial weight loss - (15kg) in some patients - produces T2DM remission in which all signs and symptoms of the condition disappear, while in other patients it does not. Using detailed metabolic tests and specially developed MRI scans, Taylor observed that fat levels in the blood, pancreas and liver were abnormally high in people with T2DM. But after following an intensive weight loss regimen, all participants in the study were able to lower their fat levels. As fat decreased inside the liver and the pancreas, some participants also experienced improved functioning of their pancreatic beta cells, which store and release insulin, controls the level of sugar in their blood and facilitates glucose to pass into their cells as a source of energy. The likelihood of regaining normal glucose control depends on the ability of the beta cells to recover. But, losing less than 1gm of fat from your pancreas through diet can re-start your normal production of insulin and thereby reverse T2DM.
 
“The good news for people with T2DM is that our work shows that you are likely to be able to reverse T2DM by moving that all important tiny amount of fat out of your pancreas. At present, this can only be done through substantial weight loss,” says Taylor.

While a significant proportion of participants in Taylor’s study responded to the weight loss program and achieved T2DM remission, others did not. To better understand this, researchers focused on 29 participants who achieved remission after dieting and 16 who dieted but continued to have T2DM. Taylor and his colleagues observed that people who were unable to restart normal insulin production had lived with T2DM for a longer time than those that could. Individuals who had lived with T2DM for an average of 3.8 years could not correct their condition through weight loss, while those who had the condition for an average of 2.7 years were able to regain normal blood sugar control.

“Many [patients] have described to me how embarking on the low-calorie diet has been the only option to prevent what they thought - or had been told - was an inevitable decline into further medication and further ill health because of their diabetes. By studying the underlying mechanisms, we have been able to demonstrate the simplicity of T2DM and show that it is a potentially reversible condition. but commencing successful major weight loss should be started as early as possible,” says Taylor.
 
Click on Newcastle University to find out more information about reversing T2DM by weight loss.
 
Bridging the gap between science and policy

Taylor and his colleagues describe their research findings as “very exciting” because “they could revolutionise the way T2DM is treated”, but caution that a series of management issues will need to be overcome before their therapy becomes common practice. This includes, (i) familiarizing primary care doctors and T2DM patients with the treatment regimen, (ii) establishing a generally accepted standard for what actually constitutes “remission”. Taylor and colleagues recommend “remission” to be when a patient has not taken diabetes medicines for at least two months and then has two consecutive HbA1c levels, taken two months apart, which are less than 6.5%. Researchers also recommend that data on T2DM reversal rates should be routinely collected, stored, analysed and reported.

Notwithstanding, the ‘elephant in the room’ is the vast extent of diabesity, the eye-watering rate at which it is growing and the general ineffectiveness of policy makers and prevent programs to dent the burden. Research findings presented at the 2018 European Congress on Obesity in Vienna emphasize the magnitude of the problem. If current trends continue, almost a quarter (22%) of the world’s population will be obese by 2045 (up from 14% in 2017), and 12% will have T2DM (up from 9% in 2017). Findings also suggest that in order to prevent the prevalence of T2DM from going above 10% by 2045, global obesity levels must be reduced by 25%. The problem is no less grave at the national level. For example, in the UK, if current trends continue obesity will rise from 32% today to 48% in 2045, while diabetes levels will rise from 10.2% to 12.6%, a 28% rise. This is unsustainable. Here’s the challenge for policy makers.

To stabilise UK diabetes rates over the next 25 years at 10%, which is high and extremely costly, obesity prevalence must fall from 32% to 24%. Similarly, in the US, if current trends continue over the next 25 years, then to keep diabetes rates stable over the same period, obesity in the US would have to be reduced by 10%: from 38% today to 28%.
 
Takeaways

Taylor and his colleagues have delivered a simple and cheap solution to one of the biggest burdens of the 21st century. But unless there is effective strategy to implement this solution the four decades of research undertaken by Taylor and his colleagues will be wasted. Previous Commentaries have described the vast and crippling burden of diabesity and the failure of well-funded programs to make any significant dent in this vast and escalating burden, which is out of control. We have suggested, this is partly because, at the operational level, programs have tended to be predicated upon inappropriate, old fashioned, 20th century organizational methods and technology and focused on “activities” rather than “outcomes”. At a policy level, government agencies have systematically failed to slow the rise of processed food becoming the “new tobacco”.  Most UK endeavours to reduce the burden of diabesity are like putting up an umbrella to fend off a tsunami. This must change if we are to harness and effectively deploy the research findings of Professor Taylor et al.
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6 years, 9 months ago

Excess weight and type-2 diabetes linked to 16% of cancers in the UK

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  • 16% of cancers in the UK are linked to excess weight and type-2 diabetes (T2DM)
  • 62% of adults are overweight or obese in England
  • 4m people are living with T2DM in the UK and another 12m are at increased risk of T2DM
  • Prevalence rates of both obesity and T2DM are rising
  • Ineffective prevention initiatives should be replaced with effective ones if we are to dent the vast and escalating burden of obesity, T2DM and related cancers
  • Public health officials, clinicians and charities need to abandon ineffective inertia projects embrace innovation and look to international best practice 

 
Excess weight and type-2 diabetes linked to 16% of cancers in the UK
 
 
Being overweight and living with type-2 diabetes (T2DM) is a potentially deadly combination because it significantly increases your risk of cancer and contributes to the projected increase in cancer cases and deaths in the UK. Findings of a study published in the February 2018 edition of The Lancet Diabetes and Endocrinology suggest that a substantial number of UK cancer cases are linked to a combination of excess body mass index (BMI) and T2DM, which here we refer to as diabesity. To lower the growing burden of cancer associated with diabesity, more effective prevention strategies will be required. To achieve this, clinicians, public health officials and charities will need to reappraise their current projects, innovate, and learn from international best practice. 
 
BMI, obesity and T2DM defined
 
Body mass index (BMI) is a simple index of weight-for-height that is commonly used to classify overweight and obesity in adults. It is a person's weight in kilograms divided by the square of his height in meters (kg/m2). Overweight is a BMI greater than or equal to 25; and obesity is a BMI greater than or equal to 30. T2DM is a long-term metabolic disorder characterized by high blood glucose (sugar), insulin resistance, and relative lack of insulin. Insulin is a hormone produced in the pancreas, which is used by the body to manage glucose levels in the blood and helps the body to use glucose for energy.

 In this Commentary
 
This Commentary describes the findings of a study reported in a 2018 edition of The Lancet Diabetes and Endocrinology, which suggests that current initiatives to prevent and reduce the burden of diabesity are ineffective. Previous Commentaries have described the Mexican Casalud and the Oklahoma City projects, which have successfully reduced obesity and type-2 diabetes (T2DM). These represent innovative international best practice, which have been largely gone unnoticed by the UK’S diabetes establishment. Also, we describe findings of a study published in the May 2017 edition of Scientific Reports, which suggests that although Google trend data can detect early signs of diabetes, they are underutilized by traditional diabetes surveillance models. The prevalence of diabesity in the UK is significant and growing so fast that public health officials, clinicians and charities will have to replace failing inertia projects with more effective ones if they are to dent the growing burden of cancer linked to a combination of obesity and T2DM.
 
The Lancet Diabetes and Endocrinology study
 
A comparative risk assessment study published in The Lancet Diabetes and Endocrinology was carried out by researchers from Imperial College London, Kent University and the World Health Organization. It suggests that in 2012, 5.6% of all cancers worldwide were linked to the combined effect of obesity and diabetes, which corresponded to about 0.8m new cancer cases. 25% of these account for liver cancer in men, and 38% account for endometrial cancer, which affects the lining of the womb in women.
 
Obesity T2DM and cancer
 
There is a close association between obesity and T2DM. The likelihood and severity of T2DM are closely linked with BMI. If you are obese your risk of T2DM is 7-times greater than someone with a healthy weight. If you are overweight your risk of T2DM is 3-times greater. Whilst it is known that the distribution of body fat is a significant determinant of increased risk of T2DM, the precise mechanism of association remains unclear. It is also uncertain why not all people who are obese develop T2DM and why not all people with T2DM are either overweight or obese. Also, the link between obesity and some cancers is well established. More recently, researchers have linked diabetes to several cancers, including liver, pancreatic and breast cancer. The 2018 Lancet Diabetes and Endocrinology study described in this Commentary is the first time anyone has calculated the combined effect of excess BMI and T2DM on cancer worldwide.
 
Findings

According to the Lancet study’s findings, cancers diagnosed in 2012, which are linked to diabesity are almost twice as common in women (496,700 cases) as men (295,900 cases). The combination of excess BMI and T2DM risk factors in women accounts for the highest proportion of breast and endometrial cancer: about 30% and 38% respectively. In men, the combination accounts for the highest proportion of liver and colorectal cancers. Overall, the biggest proportion of cancers linked to diabesity is found in high income western nations, such as the UK (38.2% of 792,600 cancer cases diagnosed in 2012), followed by east and southeast Asia (24.1%). 16.4% of cases of cancer in men and 15% in women in high income western nations are linked to being overweight, compared to 2.7% and 3% respectively in south Asia. Researchers suggest that on current trends, the number of cancers linked to a combination of excess BMI and T2DM could increase by 30% by 2035, which would take the worldwide total of these cancers from 5.6% to 7.35%. 
Uneven prevalence of cancers resulting from diabesity

While cancers associated with diabesity are a relatively small percentage of the total - the global 5.6% masks wide national variations of cancer prevalence resulting from diabesity. For example, in high income western nations, such as the UK, 16% of cancers are linked to excess BMI and T2DM, which suggests a potentially significant trend. As known cancer risk factors such as smoking tobacco have declined in the UK and other wealthy nations, so diabesity has increased as a significant risk factor.
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According to Jonathan Pearson-Stuttard,of Imperial College London and lead author of the 2018 Lancet study, the prevalence of cancer linked to excess BMI and diabetes is, “particularly alarming when considering the high and increasing cost of cancer and metabolic diseases. As the prevalence of these cancer risk factors increases, clinical and public health efforts should focus on identifying optimal preventive and screening measures for whole populations and individual patients”.
 
Risks of cancer and their vast and escalating costs

Clinicians, public health officials and charities are mindful of the vast and escalating risks of excess BMI and T2DM on cancer. According to Diabetes UK, 4.5m people are living with diabetes in the UK, 90% of these have T2DM, and another 11.9m are at increased risk of T2DM. Research published in the May 2016 edition of the British Medical Journal reports that prevalent cases of T2DM in the UK more than doubled between 2000 and 2013: from 2.39% to 5.32%, while the number of incident cases increased more steadily.
 
According to a 2014 report by Public Health England entitled “Adult obesity and type-2 diabetes”, the direct annual economic cost of patient care for people living with T2DM in 2011 was £8.8bn; the indirect costs, such as lost production, were about £13bn, and prescribing for diabetes accounted for 9.3% of the total cost of prescribing in 2012-13. The Report concludes, “the rising prevalence of obesity in adults has led, and will continue to lead, to a rise in the prevalence of type 2 diabetes. This is likely to result in increased associated health complications and premature mortality . . . Modelled projections indicate that NHS and wider costs to society associated with overweight, obesity and type 2 diabetes will rise dramatically in the next few decades”.
 
Preventing excess BMI and T2DM as a way to reduce the burden of cancer

Because of the increasing prevalence of diabesity clinicians, healthcare providers and charities have invested substantially in programs to prevent obesity and T2DM. Notwithstanding, the UK’s record of reducing the burden of these disorders is poor. According to the authors of The Lancet study, “Population-based strategies to prevent diabetes and high BMI have great potential impact … but have so far often failed.” Despite an annual NHS spend of £14bn on diabetes care, and over £20m spent annually by Diabetes UK  on “managing diabetes, transforming care, prevention, understanding and support”, over the past 10 years people with diabetes have increased by 60%.
 
Healthier You a national diabetes prevention program

Healthier You, a joint venture between NHS England, Public Health England and Diabetes UK was launched in 2016 and aims to deliver evidence-based behaviour change interventions at scale to people at high risk of T2DM to support them in reducing their risk. In December 2017, an interim analysis of the program’s performance was published in the journal Diabetic Medicine. Findings suggest that Healthier You has achieved higher than anticipated numbers of referrals: 49% as opposed to 40% projected, and the, “characteristics of attendees suggest that the programme is reaching those who are both at greater risk of developing Type 2 diabetes and who typically access healthcare less effectively.”
 
Cautionary note
 
Notwithstanding, the study’s authors conclude with a cautionary note and say that when data become available from the 2019 National Diabetes Audit (NDA) they will be better positioned to assess the program’s performance. Specifically, whether Healthier You participants changed their weight and HbAc1 levels over time. (HbA1c is a blood test that indicates blood glucose levels and is the main way T2DM is diagnosed). We are mindful that earlier National UK Diabetes Audits suggest there are significant challenges associated with incomplete and inconsistent patient data at the primary care level, and also significant variation in diabetes care across the country. It seems reasonable to assume that incomplete and inconsistent data will present analytical challenges.
 
Outcomes as key performance indicators
 
Notwithstanding, the authors of the interim appraisal of Healthier You are right to attempt to link key performance indicators (KPI) with patient outcomes rather than provider activities, which tend to be the preferred performance indicators used by public officials, clinicians and charities engaged in preventing obesity and T2DM. At the population level, there is a dearth of data that associate specific prevention programs with the reduction of the prevalence of obesity and T2DM. Until actual patient outcomes become the key performance indicators, it seems reasonable to suggest that inertia rather than innovation in prevention and care of T2DM and obesity will prevail, and year-on-year the burden of diabesity and associated cancers will continue to increase.
 
Casalud

Two significant and effective innovations to reduce excess BMI and T2DM, which have been largely ignored by the UK’s diabetes establishment are the Casalud and Oklahoma City projects. Casalud is a nation-wide online continuing medical education program launched in Mexico in 2008, which has demonstrated influence on the quality of healthcare, and subsequent influence on patient knowledge, disease self-management, and disease biomarkers. Casalud provides mHealth tools and technical support systems to re-engineer how primary care is delivered in Seguro Popular (Mexico’s equivalent to NHS England) primary health clinics.  By focusing on prevention and using technology, Casalud has increased the number of diabetes screenings and improved clinical infrastructure. An appraisal of the program published in the October 2017 edition of Diabetes, Metabolic Syndrome and Obesity suggests that the Casalud program successfully impacts changes in obesity and T2DM self-management at the primary care level throughout the country.
 
Oklahoma city’s transformation

Oklahoma is a city of about 550,000 people. In 2007, it was dubbed America’s “fast food capital" and “fattest city". A decade later, the city was in the middle of a transformation. While the state still has among the highest adult obesity rates in the nation – climbing from 32.2% to 33.9% between 2012 and 2015 – obesity rates in Oklahoma City dropped from 31.8% to 29.5% during that time frame, according to the US Centers for Disease Control and Prevention data. The city’s transformation started with city’s Mayor Mick Cornett. Cornett, who has been in office since 2004, brought notoriety to the city’s public health efforts beginning at the end of 2007 with the goal to collectively lose 1m pounds. The people of Oklahoma City met that goal in 2012, but have not slowed down their efforts. What began as a campaign to promote healthy eating and exercise became a citywide initiative to, "rebuild the built environment and to build the city around people instead of cars," Cornett says.
 
Underutilized data that detect early people at risk of T2DM
 
Findings of a study published in the May 2017 edition of Scientific Reports suggest an innovative way to improve early diagnosis of excess BMI and T2DM when the diseases are easier and less costly to treat, but so far these data are underutilised. The study reports that increasingly people are searching the Internet to assess their health and records of these activities represent an important source of data about population health and early detection of T2DM. The study based on data from the 2015 Digital Health Record produced by Push Doctor, a UK based online company, which has over 7,000 primary care clinicians available for online video consultations. According to the study, which is based on 61m Google searches and a survey of 1,013 adults, 1 in 5 people chose self-diagnosis online rather than a consultation with their primary care doctor. The study makes use of commercially available geodemographic datasets, which combine marketing records with a number of databases in order to extract T2DM candidate risk variables. It then compares temporal relationships with the search keywords used to describe early symptoms of the T2DM on Google. Researchers suggest that Google Trends can detect early signs of T2DM by monitoring combinations of keywords, associated with searches. Notwithstanding, the value of these data they are underutilized by clinicians, public health officials and charities engaged in reducing the risks of excess BMI and T2DM, which can lead to cancer.
 
Takeaways

Over the past decade, NHS England has spent more than £100bn on diabetes treatment alone, and Diabetes UK has spent some £200m on education and awareness programmes, yet diabetes in the UK has increased by 60%. 90% of diabetes cases are T2DM, which is closely linked to obesity. The combination of excess BMI and T2DM causes some 16% of all cancers in the UK. The burden of these diseases destroys the lives of millions and cost billions. It is imperative that this vast and escalating burden is dented. This will not be achieved if clinicians, public health officials and charities continue with ineffective inertia projects. They will need innovate and embrace best practice if they are to prevent and reduce the vast and escalating burden of excess BMI, T2DM and cancer.
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7 years, 11 months ago

Weight loss surgery to treat T2DM

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  • 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, 6 months ago

Will the UK’s diabetes prevention program work?

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  • 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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