Gastric bypass with or without truncal vagotomy to improve remission of type 2 diabetes
Effects on Remission of Type 2 Diabetes Mellitus Following Roux-en-Y Gastric Bypass Alone vs Roux-en-Y Gastric Bypass Combined With Truncal Vagotomy: A Triple-Blind Randomized Controlled Trial.
This trial tests whether adding truncal vagotomy to Roux-en-Y gastric bypass helps adults with obesity and type 2 diabetes reach diabetes remission more often than gastric bypass alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 68 Years |
| Sex | All |
| Sponsor | University Research Institute for the Study of Genetic & Malignant Disorders in Childhood Academic / other |
| Locations | 2 sites (Athens, Attica and 1 other locations) |
| Trial ID | NCT07278115 on ClinicalTrials.gov |
What this trial studies
This randomized, triple-blind, controlled trial enrols adults with obesity and type 2 diabetes to compare standard Roux-en-Y gastric bypass (RYGB) with RYGB plus truncal vagotomy. Participants are randomized to one of the two surgical approaches and followed to measure diabetes remission, glycemic control, and hormonal changes. The protocol is based on a neurohormonal hypothesis that interrupting vagal signaling will reduce biliopancreatic output and duodenal-driven hormonal hyperstimulation, improving insulin sensitivity beyond weight loss alone. Eligibility includes adults 18–68 years with BMI ≥30 kg/m² and specified diabetes and Advanced‑DiaRem score criteria.
Who should consider this trial
Good fit: Adults aged 18–68 with BMI ≥30 kg/m² and confirmed type 2 diabetes who meet the trial's HbA1c and Advanced‑DiaRem score criteria and have no prior major abdominal surgery or disqualifying comorbidities.
Not a fit: Patients with type 1 diabetes, prior bariatric or major abdominal surgery, uncontrolled major medical conditions, chronic corticosteroid use, or active substance abuse are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding truncal vagotomy could increase diabetes remission rates and reduce reliance on diabetes medications beyond what gastric bypass alone achieves.
How similar studies have performed: Roux-en-Y gastric bypass alone is proven to induce diabetes remission in many patients, but the addition of truncal vagotomy is a novel strategy with limited prior human evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI ≥ 30 kg/m² * Age: 18-68 years * Confirmed type 2 diabetes mellitus with: * HbA1c ≥ 6.5%, or * HbA1c ≥ 6.1% and the use of antidiabetic medication * Advanced-DiaRem Score \> 5\* \* Advanced-DiaRem Score: a validated scoring system predicting diabetes remission after bariatric surgery. Exclusion Criteria: * Previous bariatric surgery or major abdominal surgery (e.g., enterectomy, gastrectomy, colectomy, hepatectomy, partial or total pancreatectomy) * Major, uncompensated health problems (major psychiatric, endocrine, cardiac, pulmonary, hepatic, or renal disorder; cancer; or other conditions with increased risk of complications) * Use of corticosteroids (glucocorticoids): * Chronic corticosteroid use for \> 3 months within the last year, or * Corticosteroid therapy within the last 3 months * Type 1 diabetes mellitus * Alcohol or drug addiction
Where this trial is running
Athens, Attica and 1 other locations
- Diabetes Surgery — Athens, Attica, Greece (Recruiting)
- Diabetes Surgery — Athens, Attica, Greece (Not_yet_recruiting)
Study contacts
- Study coordinator: Athena N Kapralou, MD, PhD
- Email: athinakapralou@gmail.com
- Phone: +306945750599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.