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

NCT07622992 · Not yet recruiting

Last updated 2026-07-12

This clinical trial is testing whether a medication called tirzepatide, a ketogenic diet, or standard care before weight-loss surgery helps people with obesity and related conditions lose more weight one year after the procedure.

Status Not yet recruiting Approved but enrollment has not started.

Type Observational

Participants 96 people Planned (estimated).

Who can join Ages 18–65 · all sexes

Timeline Started 2026-07 · est. completion 2029-12

Where 1 site · Italy

What this study is testing ClinicalTrials.gov NCT07622992 ↗

Description as written by the study sponsor.

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.

Main thing measured	Percentage of Total Weight Loss at 1 Year Post-Surgery
Sponsor	Mario Musella MD
Conditions studied	Obesity (BMI > 35) and Diabetes Mellitus, Obesity (BMI > 35) and Dyslipemia, Obesity (BMI > 35) and High Blood Pressure
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07622992 ↗