Laparoscopic sleeve gastrectomy versus conventional medical therapy in patients with newly diagnosed type 2 diabetes and body mass index 30–42 Kg/m2: 1-year results of a randomized clinical trial

Purpose Evidence supporting metabolic bariatric surgery (MBS) for type 2 diabetes (T2D) comes from randomized trials in patients with long-standing, advanced, or refractory disease. This study aimed to evaluate MBS as an initial treatment in patients with newly diagnosed, early-stage, treatment-responsive T2D, an indication that has not been previously directly investigated. Methods In this multicenter, open-label, randomized trial, 30 participants (BMI 30–42 kg/m²; T2D duration ≤ 8 months; no insulin use or diabetes-related complications) were randomized 1:1 to laparoscopic sleeve gastrectomy plus conventional medical therapy (LSG + CMT; MBS) or CMT alone. Follow-up was 12 months. The primary endpoint was diabetes resolution (HbA1c ≤ 6.0% without glucose-lowering therapy; intention-to-treat). Secondary endpoints (per-protocol) included diabetes remission (current ADA criteria), glycometabolic and cardiometabolic parameters, renal indices, weight loss, quality of life, and safety. Results Of 30 randomized participants, 26 completed follow-up. Diabetes resolution occurred in 86.7% of the MBS group versus 13.3% of the CMT group ( P = 0.00014). Diabetes remission was achieved in 100% of the MBS group, compared with 15.4% ( P < 0.0001). MBS led to greater HbA1c reduction (− 0.9% vs. − 0.1%; P = 0.04) with substantial weight loss (− 26% body weight; P < 0.001). Two surgical complications occurred and were successfully managed. Conclusions Early MBS led to significant glycometabolic improvement and higher rates of diabetes resolution and diabetes remission than CMT alone. Primarily due to the limited sample size and short follow-up, our findings, although promising, require confirmation in larger, long-term studies that also assess the potential effects of early MBS on diabetic complications. Trial registration ClinicalTrials.gov: NCT02488733, first submitted: 2015-06-30.