Effects on Remission of Type 2 Diabetes Mellitus Following Gastric Bypass Alone vs Gastric Bypass Combined With Truncal Vagotomy
Recruiting · NCT07278115 · Interventional (participants receive a specific treatment) · Lead sponsor: University Research Institute for the Study of Genetic & Malignant Disorders in Childhood
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 homeostasis and hormonal adaptation. Design: Eligible adults (18-65 years) with BMI ≥30 kg/m² and confirmed T2DM (HbA1c ≥6.5%, or on antidiabetic therapy with HbA1c ≥6.1%) will be randomized to: 1. RYGB alone, or 2. RYGB with truncal vagotomy. Participants, postoperative staff, and assessors will remain blinded to allocation. Primary Outcome: Remission of T2DM at 12 months postoperatively, defined as fasting plasma glucose \<100 mg/dL and HbA1c \<6.0% without antidiabetic medication for at least one year. Secondary Outcomes: Changes in HbA1c, fasting glucose, insulin, C-peptide, OGTT-derived indices, GLP-1, CCK, PYY, GLP-2, oxyntomodulin responses, HOMA-IR, body composition, cardiovascular risk markers, medication use, and quality-of-life parameters. Surgical metrics include hospital stay, readmissions, complications, gastrointestinal symptoms, nutritional deficiencies, and bone density changes. Follow-Up: Assessments occur preoperatively and at 1, 3, 6, and 12 months after surgery. Significance: The VagusSx Trial tests whether targeted vagal and duodenal pathway interruption can improve glycemic control beyond weight loss alone, offering a novel, physiology-based strategy for durable diabetes remission.
Who can take part
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 it is running
2 locations listed.
- Diabetes Surgery - Athens, Attica, Greece
- Diabetes Surgery - Athens, Attica, Greece