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
In brief
Sleeve gastrectomy resolves diabetes in 87% versus 13% with medication
In a 12-month randomized trial of 30 adults with early-stage type 2 diabetes and BMI 30-42, laparoscopic sleeve gastrectomy plus standard care achieved diabetes resolution in about 87% of patients, compared with only 13% on medication alone, and produced a 26% weight loss. The procedure was safe in this small cohort, but larger, longer studies are needed to confirm durability and impact on complications.
- Journal
- Journal of endocrinological investigation (Q1)
- Published
- 13 August 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Stefano Trastulli, Amilcare Parisi, Ilenia Grandone, Lucia Fontana, Jacopo Desiderio, Diana Giannarelli, et al.
- PMID
- 42593716
- DOI
- 10.1007/s40618-026-03021-z
Why clinicians should know about it
- Picked for Bariatric and Metabolic Surgery (top studies of the week, 16 August 2026): Randomized trial of sleeve gastrectomy vs medical therapy
Abstract
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.