Medical therapy

10-year RCT analysis suggests metabolic surgery is best medical therapy for T2D control

Data from a follow-up analysis of a randomized controlled trial suggest that weight loss surgery may be a more effective strategy than conventional medical therapy for the long-term control of type 2 diabetes.

A 10-year follow-up to a trial comparing metabolic surgery to medical therapy in patients with type 2 diabetes, findings suggest metabolic surgery may be more effective than conventional medical therapy in facilitating long-term control type 2 diabetes, with 37.5% of operated patients maintaining an HbA1c below 7.0% at 10 years.

“The results of this study provide the strongest scientific evidence to date that type 2 diabetes in its own right is a curable disease, not necessarily progressive and irreversible. Additionally, to represent a major advance in the treatment of diabetes, metabolic surgery is our best lead to the elusive cause of the disease,” Francesco Rubino, MD, chair of bariatric and metabolic surgery at King’s College London, said in a statement.

Interested in describing the effects of conventional therapy versus metabolic surgery, Rubino and a team of colleagues performed a follow-up analysis of a randomized clinical trial they had previously conducted at a hospital in Rome, Italy. Italy. The trial randomized a cohort of 60 patients in a 1:1:1 ratio to undergo Roux-en-Y gastric bypass (RYGB), biliopancreatic diversion (BPD) or medical treatment plus lifestyle interventions . The primary endpoint of the trial was diabetes remission at 2 years.

To be included in the initial trial, patients had to be between the ages of 30 and 60, have a BMI of 35 kg/m2 or more, a history of type 2 diabetes for at least 5 years and an HbA1c greater than 7, 0%. As part of the trial design, participants attended scheduled visits at baseline, then at 1, 3, 6, 9, and 12 months, every 6 months through 60 months, and annually through continued.

The primary outcome of the current analysis was the durability of diabetes remission at 10 years. The researchers defined diabetes remission as the combination of fasting blood sugar below 100 mg/dL and HbA1c below 6.5% without ongoing pharmacological treatment for at least 1 year.

Of the 60 patients who were randomized, 57 had data from 10-year follow-up visits. When examining people undergoing surgery, investigators found that 37.5% maintained diabetes remission throughout the 10-year period. In intention-to-treat analyses, 10-year remission rates were 5.5% (95% CI, 1.0-25.7) for medical treatment, 50.0% (95% CI , 29.9-70.1) for borderline personality disorder and 25.0% (95% CI, 11.2-46.9) for RYGB (P=.0082).

At 2 years, 34 participants in the entire study cohort had achieved remission, but investigators noted that 20 people in this group had a relapse of hyperglycemia during the follow-up period. However, the researchers pointed out that all of the relapsed individuals had adequate glycemic control at the 10-year follow-up.

Further analysis revealed that those who underwent RYGB or BPD had fewer diabetes-related complications than those in the medical treatment group (RR, 0.07; 95% CI, 0.01-0.48). Of note, serious adverse events occurred more often in the BPD group compared to medical treatment (OR, 2.7; 95% CI, 1.3-5.6), but this increased risk did not not observed when comparing the RYGB group to medical treatment (OR, 0.7; 95% CI, 0.3-1.9).

“These data support the idea that surgery may be a cost-effective approach to treating type 2 diabetes. The evidence is now more than compelling that metabolic surgery should be considered a primary treatment option for the treatment of patients with diabetes. severe type 2 and obesity,” added Rubino.

This study, “Metabolic surgery versus conventional medical therapy in patients with type 2 diabetes: 10-year follow-up of an open-label, single-center randomized controlled trial”, was published in The Lancet.