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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 bypassgastric 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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  • 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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