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Effects on Remission of Type 2 Diabetes Mellitus Following Gastric Bypass Alone vs Gastric Bypass Combined With Truncal Vagotomy

RecruitingNAAges 18 Years - 68 YearsAllUniversity Research Institute for the Study of Ge…
NCT07278115 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized, triple-blind clinical trial investigates whether adding truncal vagotomy to Roux-en-Y gastric bypass (RYGB) enhances remission of type 2 diabetes mellitus (T2DM) in patients with obesity. The study explores whether modulation of vagal signaling provides superior metabolic outcomes compared to standard RYGB alone. Background: RYGB is a proven metabolic procedure capable of inducing diabetes remission; however, the mechanisms remain incompletely defined. Emerging evidence supports a duodenum-centered neurohormonal model suggesting that amplified digestion-driven by vagal and hormonal hyperstimulation-plays a key role in the development of insulin resistance. The vagus nerve regulates pancreatic and biliary secretion, as well as gut hormone release. By combining truncal vagotomy with RYGB, the study aims to attenuate vagal overactivation and evaluate its impact on glucose

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📋 Eligibility rules (as published)
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
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What it tests

  • Roux-en-Y Gastric Bypass plus Truncal Vagotomy
  • Roux-en-Y Gastric Bypass
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Where

2 sites
Diabetes Surgery
Athens, Greece
Diabetes Surgery
Athens, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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