Clinical Trial

Preoperative Optimization With Tirzepatide, Ketogenic Diet, or Standard Care Before One Anastomosis Gastric Bypass Surgery

Study acronym: OPTI-OAGB
Not Yet Recruiting
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Summary
This study compares three preoperative strategies before one anastomosis gastric bypass(OAGB) for severe obesity. Participants will be assigned to receive either tirzepatide medication for 60 days, a ketogenic diet for 4 weeks, or standard care before surgery. The main goal is to determine which approach leads to the best weight loss one year after surgery. The study will also evaluate safety, surgical outcomes, and improvement of obesity-related health conditions such as diabetes, high blood pressure, and sleep apnea.
Trial Details
NCT Number NCT07622992
Lead Sponsor Mario Musella MD
Conditions Obesity (BMI > 35) and Diabetes Mellitus, Obesity (BMI > 35) and Dyslipemia, Obesity (BMI > 35) and High Blood Pressure
Enrollment 96 participants
Start Date 2026-07-01
Primary Completion 2029-07-01 (estimated)
Study Completion 2029-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-03