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The results of a randomized clinical trial with the longest follow-up to date show that metabolic surgery is more effective than medication and lifestyle interventions in long-term control of severe type 2 diabetes.
The study, published today in The Lancet, also shows that more than a third of surgically treated patients remained diabetes-free during the 10-year trial period. This shows, in the most rigorous clinical investigation, that a “cure” for type 2 diabetes can be achieved.
Researchers from King’s College London and the Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy, report on the 10-year results of a study comparing metabolic surgery with conventional medical and lifestyle interventions in patients with type 2 diabetes.
The study enrolled 60 patients with advanced type 2 diabetes and was treated in a large academic hospital in Rome, Italy. Patients were randomly assigned medication plus lifestyle interventions or metabolic surgery (gastric bypass or biliopancreatic distraction). At the start of the study, all patients had a serious illness with poorly controlled blood sugar levels and a history of diabetes for more than five years.
The study’s results show that 37.5% of surgically treated patients were able to maintain non-diabetic glycemia without the need for diabetes medication – a condition known as diabetes remission – for the duration of the 10-year study period. In 2009, the American Diabetes Association defined the “cure” for diabetes as a five-year state of disease remission.
Professor Francesco Rubino, Senior Report Author and Chair of Bariatric and Metabolic Surgery at King’s College London and Consultant Surgeon at King’s College Hospital, London, said: “The results of this study provide the most robust scientific evidence yet of this full blown Type 2 diabetes is one a curable disease that is not necessarily progressive and irreversible. In addition to a major advance in the treatment of diabetes, metabolic surgery is our best route to the elusive cause of the disease. “
Compared to conventional medical treatment, the surgery also resulted in better overall metabolic control, lower cardiovascular risk, better kidney function, and better quality of life. In particular, surgically treated patients had a significantly lower incidence of complications related to diabetes, including cardiac, renal, and neurological adverse events. Metabolic surgeries also reduced drug consumption, including drugs for diabetes, high blood pressure, and dyslipidemia.
The study examined the early and long-term safety of the various intervention strategies. Patients who received biliopancreatic distraction were more likely to have serious adverse events, including events associated with both illness and intervention, compared to subjects in both other groups. Patients treated with conventional medical therapy had a significantly higher incidence of serious adverse events than patients who had undergone Roux-en-Y gastric bypass surgery.
Professor Geltrude Mingrone, first author of the report, professor of medicine at the Catholic University of Rome and professor of diabetes and nutrition at King’s College London, said: “These data confirm the notion that surgery can be a cost-effective approach to treating Type 2 diabetes The evidence today is more than convincing that metabolic surgery should be considered the primary therapeutic option for the treatment of patients with severe type 2 diabetes and obesity. “
Previous studies had shown that bariatric or weight loss surgery can induce long-term remission from diabetes in patients with very severe obesity. However, most patients undergoing traditional weight loss surgery typically have mild or recent diabetes. This study shows the potential curative effects of metabolic surgery in patients with severe disease.
Diabetes is a leading cause of mortality and morbidity in Western societies and significantly increases the risk of severe COVID-19 and mortality from the virus. Despite the evidence that surgery can rapidly and dramatically improve diabetes, less than 1% of surgical candidates in most countries have access to metabolic surgery. In addition, metabolic surgery has been withheld even longer than other elective surgery during the current pandemic.
Professor Rubino added, “Metabolic surgery is arguably the most effective therapy available for type 2 diabetes and can be a life-saving option for many patients. It should be given appropriate priority in this pandemic and beyond.”
Delay in bariatric and metabolic surgery during the COVID-19 pandemic puts patients at risk, experts warn. Provided by King’s College London
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