Trial Backs Metabolic Surgical procedure as Lengthy-Time period Diabetes Treatment

0
53

For long-term diabetes remission, metabolic surgery is an effective option, according to 10-year data.

In a randomized study with 60 patients with type 2 diabetes and obesity, the remission rates of diabetes in the years after the operation were significantly higher than in conventional medical therapy. Geltrude Mingrone, MD, PhD, of King’s College London, UK, and colleagues reported in The Lancet.

In previously reported 2-year results, 75% of patients who had Roux-en-Y gastric bypass (RYGB) and 95% of patients who had biliopancreatic diversion (BPD) achieved diabetes Remission, defined as HbA1c below 6.5% and fasting glucose below 100 mg / dl (5.55 mmol / l) without ongoing pharmacological medication for at least 1 year.

In the newly reported 10-year results of the same patients, 50% of the patients with BPD maintained their diabetes remission through year 10 (50%, 95% CI 29.9-70.1%), while a quarter of the patients with BPD Treated RYGB maintained remission for 10 years after surgery (25%, 95% CI 11.2-46.9%, P = 0.0082).

On the other hand, only 5.5% (95% CI 1.0-25.7%) of those who received non-surgical medical therapy for their diabetes achieved and maintained long-term remission a decade later. Notably, this actually only included one participant who went into diabetes remission after moving to the surgical group.

“It has been shown that no patient is in diabetes remission after medical therapy,” the researchers said.

Overall, around 38% of all operated patients maintained their diabetes remission during the ten-year follow-up period. Also, no patient who did not achieve remission within the first 2 years achieved it later.

“This factor could help us intensify modern and effective glucose-lowering therapies such as SGLT2 inhibitors and GLP-1 receptor agonists earlier after metabolic surgery,” suggested the authors of an accompanying comment, Alexander Miras, MRCP, PhD, of Imperial College London. and Carel le Roux, MBChB, MSc, PhD, from University College Dublin, Ireland.

“The combination of metabolic surgeries and glucose-lowering agents could have a positive impact not only on glycemic results, but also on preventing the macrovascular and microvascular complications of type 2 diabetes,” added Miras and le Roux.

Among surgical patients who achieved diabetes remission 2 years after surgery, a greater percentage of RYGB patients relapsed into hyperglycemia compared to BPD patients.

After 2 years of remission, about 67% (95% CI 41.7-84.8%) of the RYGB patients had a relapse compared to 53% (95% CI 31.7-72.7%) of the BPD patients. What is important, however, is that all of these patients who relapsed diabetes 2 years later were able to maintain “reasonable” glucose control through the 10th year with an average HbA1c of 6.7%.

The median diabetes-free survival time was 9 years for the BPD patients and 5 years for the RYGB patients.

Unsurprisingly, patients who underwent either type of metabolic surgery had far fewer diabetes-related complications over the years, including macrovascular complications – particularly myocardial infarction – and microvascular diabetic complications, including retinopathy, nephropathy, and neuropathy.

Surgical patients also had significantly lower body weight, body mass index (BMI), waist circumference, homeostatic model assessment for insulin resistance scores, plasma triglycerides, and higher quality of life scores; However, no differences in blood pressure were found.

“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 appropriately prioritized in times of pandemics and beyond,” said the study’s lead author, Dr. Francesco Rubino. of King’s College London, in a statement.

The results “provide the most robust scientific evidence yet that full-blown type 2 diabetes is a curable disease that is not necessarily progressive and irreversible[ing] Metabolic surgery is a major advancement in the treatment of diabetes and our best route to the elusive cause of the disease, “he added.

The open-label single-center study enrolled 60 Italian patients – 20 patients who were randomized to be switched to laparoscopic RYGB, BPD, or conventional medical therapy plus lifestyle interventions. The BPD was performed with an open surgical approach using the Scopinaro procedure that uses a horizontal gastrectomy rather than a sleeve gastrectomy, the researchers explained. “The BPD used in this study leaves more stomach residue and has less of an impact on restricting calorie intake than the duodenal switch variant.”

Participants were 30 to 60 years old, had a BMI of 35 or greater, had at least a 5-year history of type 2 diabetes, had an HbA1c of 7% or greater, and approximately half were female. After 10 years, the mean HbA1c values ​​in the BPD group were 6.4%, in the RYGB group 6.7% and in the medical therapy group 7.6%.

Miras and le Roux praised the study not only for its long follow-up time, but also for including patients with largely advanced type 2 diabetes, as half of the participants were taking insulin at the time of surgery.

One caveat, however, was that the sample size was small, which meant there was a lack of power to really quantify the benefits of surgery for type 2 diabetes complications. In addition, the BPD procedure is rarely performed while the sheath gastrectomy procedure is currently the most popular metabolic surgery performed in the United States today.

“The 10-year data from STAMPEDE is now eagerly awaited to see how sleeve gastrectomy has performed over 10 years. However, we also hope to gain more insight into hypoglycaemia rates and long-term surgical and nutritional complications associated with all surgical procedures to obtain.” The team noted.

  • Kristen Monaco is a contributor focused on endocrinology, psychiatry, and dermatology news. She is based in New York City and has been with the company for nearly five years.

Disclosure

The study was funded by the Agostino Gemelli University Hospital Foundation IRCCS.

Mingrone and co-authors reported relationships with Novo Nordisk, Fractyl, Johnson & Johnson, Ethicon, Medtronic, GI Dynamics, and Keyron.

Miras and le Roux reported on relationships with Science Foundation Ireland, the Health Research Board, Irish Research Council, Novo Nordisk, Herbalife, Boehringer Ingelheim, Johnson & Johnson, Keyron, AnaBio and Sanofi.