MedTrace Logo

Sleeve Gastrectomy vs. Lifestyle & Medications: Impact on BMI Trajectory and Target Attainment in a Matched Cohort Study

NCT06820047 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 190

Last updated 2025-02-11

No results posted yet for this study

Summary

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.

Conditions

  • Obesity and Obesity-related Medical Conditions

Interventions

PROCEDURE

Laparoscopic sleeve gastrectomy

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.

OTHER

Obesity pharmacotherapy

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.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Lidia Castagneto Gissey, MD, PhD · University of Roma La Sapienza

Eligibility

Min Age
19 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2023-07-01
Completion
2024-07-01

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06820047 on ClinicalTrials.gov