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

NCT06820047 | Completed

• 1 other identifier: ID3361963
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

obesity; sleeve gastrectomy; semaglutide; glp-1 receptor agonist; intensive lifestyle modifications

Outcome Measures

Primary Outcomes (1)

• Weight modifications

  Change in body mass index (expressed as weight in kilograms divided by height in meters squared, kg/m\^2) at 1 year and time to reach 25% total weight loss (%TWL) (weight will be reported in kilograms)

  12 months

Secondary Outcomes (5)

• Glycemic control changes

  12 months

• Lipid profile changes

  12 months

• Comorbidity resolution rate

  12 months

• Comorbidity resolution rate

  12 months

• Comorbidity resolution rate

  12 months

Study Arms (2)

Surgical Group

Patients undergoing laparoscopic sleeve gastrectomy

Procedure: Laparoscopic sleeve gastrectomy

Medical Group

Patients undergoing intensive lifestyle modifications + semaglutide 2.4 mg once weekly

Other: Obesity pharmacotherapy

Interventions

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.

Surgical Group

Obesity pharmacotherapy 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.

Also known as: Intensive Lifestyle Modifications, Semaglutide 2.4 mg

Medical Group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the weight-loss clinic of Sapienza University Hospital and Catholic University Hospital in Rome, Italy, and eligible for bariatric surgery were allocated to intensive lifestyle modifications with obesity management medications or metabolic surgery.

You may qualify if:

• 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

You may not qualify if:

• Previous bariatric surgery;
• History of pancreatitis;
• Severe psychiatric disorders;
• Personal or familiar history of endocrine cancers.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (2)

IRCCS Catholic University of Rome

Rome, Italy, 00135, Italy

Location

Sapienza University of Rome

Rome, Italy, 00161, Italy

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lidia Castagneto Gissey, MD, PhD

  University of Roma La Sapienza

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 11, 2025
• Study Start: May 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 1 month and ending 10 years after the publication of results
• Access Criteria: IPD will be shared with qualified researchers conducting scientifically valid analyses relevant to obesity management and metabolic interventions. Access to the data will require submission of a research proposal outlining the planned analyses and statistical methods. Proposals must be reviewed and approved by an independent data access committee. A formal data-sharing agreement must be signed before access is granted. Requests can be submitted via the institutional research office at Sapienza University Hospital via email (lidia.castagnetogissey@uniroma1.it). Data access decisions will be based on scientific merit, ethical considerations, and compliance with data protection regulations.

Locations

IT (2)