Sleeve Gastrectomy vs. Lifestyle & Medications: Impact on BMI Trajectory and Target Attainment in a Matched Cohort Study
NCT06820047 · Completed
Last updated 2026-05-28This study compares the effects of weight-loss surgery (sleeve gastrectomy) with lifestyle changes and medications on body weight in adults with obesity and related health conditions.
What this study is testing ClinicalTrials.gov NCT06820047 ↗
Description as written by the study sponsor.
Obesity is a widespread and preventable condition affecting over a billion people globally, with rates expected to rise significantly by 2030. It increases the risk of chronic illnesses such as diabetes, cardiovascular disease, certain cancers, mental health issues, and premature death. While bariatric surgery, such as sleeve gastrectomy (SG), is the most effective long-term weight-loss solution, many individuals are ineligible or unwilling to undergo surgery. Semaglutide, a medication that suppresses appetite and aids in weight loss when paired with diet and exercise, offers a promising alternative. This study compared the effectiveness of SG and an intensive weight-loss program combining diet, exercise, and semaglutide. Conducted over a year with 190 participants split into two groups matched by BMI, the SG group underwent surgery, while the other group followed a calorie-restricted diet, intensive exercise, and weekly semaglutide injections. Changes in BMI, weight, and comorbidities such as diabetes and high blood pressure were evaluated, aiming to determine which approach was more effective in managing obesity.
Treatments tested
- Laparoscopic sleeve gastrectomy Procedure
Patients underwent SG, involving longitudinal resection of approximately 75% of the stomach along its greater curvature, with excision of the fundus and part of the body and antrum, preserving a portion of the latter and the pylorus itself. This results in a vertical tube-shaped gastric tube "sleeve". After surgery, patients followed a free diet. Patients were evaluated at baseline and at 1, 3, 6, 9, and 12 months after starting the intervention.
- Obesity pharmacotherapy also known as Intensive Lifestyle Modifications, Semaglutide 2.4 mg Other
Patients underwent 1 month of a very low calorie diet (VLCD) with 813 kcal/day, followed by a low calorie diet (LCD) for 11 months together with intensive physical exercise (30 min/day of brisk walking plus at least 3 h/week of aerobic exercise) with 2.4 mg/week of semaglutide (Ozempic®), given once weekly as subcutaneous injections. Patients were evaluated at baseline and at 1, 3, 6, 9 and 12 months after starting the interventions.
| Main thing measured | Weight modifications |
|---|---|
| Sponsor | University of Roma La Sapienza |
| Conditions studied | Obesity and Obesity-related Medical Conditions |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06820047 ↗