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.
Age 18 to 65 years at enrollment
Body Mass Index (BMI) between 40 and 55 kg/m² at screening visit
Appropriate candidates for bariatric surgery according to current international guidelines (IFSO 2022) with documented failure of conservative weight loss attempts
Presence of at least one obesity-related comorbidity: Type 2 Diabetes Mellitus (HbA1c at least 6.5%, fasting plasma glucose at least 126 mg/dL, 2-hour OGTT glucose at least 200 mg/dL, or use of antidiabetic medications); Hypertension (systolic BP at least 140 mmHg or diastolic BP at least 90 mmHg, or use of antihypertensive medications); Dyslipidemia (total cholesterol at least 200 mg/dL, LDL-C at least 130 mg/dL, HDL-C less than 40 mg/dL for men or less than 50 mg/dL for women, triglycerides at least 150 mg/dL, or use of lipid-lowering medications); Obstructive Sleep Apnea Syndrome (AHI at least 15 events/hour or AHI 5-14 with symptoms requiring treatment)
History of any prior bariatric procedure or major upper gastrointestinal surgery that could confound outcomes or increase surgical risk
Severe uncontrolled psychiatric disorders including active psychosis, severe depression with suicidal ideation, active substance abuse, or eating disorders (other than binge eating disorder) that could impair protocol adherence or informed consent capacity
Current pregnancy, lactation, or planning pregnancy within 18 months of enrollment (women of childbearing potential must use effective contraception throughout study period)
Contraindications to tirzepatide for patients potentially randomized to Arm A: personal or family history of medullary thyroid carcinoma; Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); history of pancreatitis; severe gastrointestinal disease (inflammatory bowel disease, gastroparesis); known hypersensitivity to tirzepatide or excipients
Patients between 18 to 65 years, with Body Mass Index (BMI) between 40 and 55 kg/m² at screening visit. The patients must be eligible for bariatric surgery according to current international guidelines (IFSO 2022) with documented failure of conservative weight loss attempts. Patients enrolled need to have at least one obesity-related comorbidity and the ability to understand study procedures and provide written consent.
Case-control
Prospective
Not listed
Percentage of Total Weight Loss at 1 Year Post-Surgery
The primary endpoint is the percentage of total weight loss (%TWL) measured at 12 months after bariatric surgery. %TWL is calculated as: \[(Baseline Weight - Weight at 12 months) / Baseline Weight\] × 100
Percentage of Excess Weight Loss at 1 Year
Percentage of excess weight loss (%EWL) calculated as: \[(Baseline Weight - Weight at 12 months) / (Baseline Weight - Ideal Body Weight)\] × 100, where Ideal Body Weight is calculated using the Devine formula
Absolute Weight Loss at 1 Year
Absolute weight loss measured in kilograms (kg), calculated as the difference between baseline weight (at randomization) and weight at 12 months post-surgery
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Mario Musella MD
Lead sponsor
Federico II University
Sponsor institution
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