NCT06820047Completed
Sleeve Gastrectomy vs. Lifestyle & Medications: Impact on BMI Trajectory and Target Attainment in a Matched Cohort Study
Impact of Sleeve Gastrectomy Versus Intensive Lifestyle Modifications With Obesity Management Medications on BMI Trajectory and Target Attainment: a Prospective Matched Cohort Study
Source: ClinicalTrials.gov · Last updated 11 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 190 (actual)
- First submitted
- 27 Jan 2025
- Start date
- 1 May 2022
- Primary completion date
- 1 Jul 2023
- Lead sponsor
- University of Roma La Sapienza
- Diseases
- Obesity
- NCT number
- NCT06820047
What you commit to
- Study type: Observational
- Participants enrolled: 190
- From 1 May 2022 to the primary completion date, 1 Jul 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous bariatric surgery;
Other illness
- History of pancreatitis;
- Severe psychiatric disorders;
- Personal or familiar history of endocrine cancers.
Who the study is looking for
- Age between 19 and 69 years with stable body weight in the past 6 months;
- BMI ≥35 kg/m2 and at least one or more obesity-related co-morbidities (T2D, hypertension, sleep apnea and other respiratory disorders, metabolic-associated fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease)
- BMI≥40 kg/m2 with or without related comorbidities
Age in the registry: 19 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Catholic University of Rome Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Sapienza University Of Rome Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.