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.