Completed

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

Lead sponsor

University of Roma La Sapienza

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

Actual enrollment

190

Study population

Bariatric Surgery, Bariatric Surgery Candidate, Obesity / overweight

Eligibility highlights

•BMI ≥35

Primary endpoint

•Weight modifications (BMI, change, ≥25% weight-loss responders)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06820047

Org study IDID3361963

Timeline

Milestones

Study start2022-05-01actual

Primary completion2023-07-01actual

Study completion2024-07-01actual

Study first posted2025-02-11actual

Last update posted2025-02-11actual

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide

Who this study enrolls

Bariatric SurgeryBariatric Surgery CandidateObesity / overweight

Who can enroll

Minimum age19 Years

Maximum age69 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

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.

Inclusion criteria

•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

Exclusion criteria

•Previous bariatric surgery;

•History of pancreatitis;

•Severe psychiatric disorders;

•Personal or familiar history of endocrine cancers.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Glycemic / diabetes

Weight & body composition

1 endpoint

Primary/protocol endpoint/low confidence

Weight modifications

Time frame:12 months

change from baseline, improvement

componentsBMI, change, ≥25% weight-loss responders

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Glycemic control changes

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Comorbidity resolution rate

Time frame:12 months

categorical status, improvement

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Lipid profile changes

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Comorbidity resolution rate

Time frame:12 months

categorical status, improvement

Secondary/protocol endpoint

Comorbidity resolution rate

Time frame:12 months

categorical status, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Russo MF, Casella G, Angelini G, Russo S, Casella-Mariolo J, D'Andrea V, Illuminati G, Castagneto-Gissey L. Impact of Sleeve Gastrectomy Versus Intensive Lifestyle Modifications With Obesity Management Medications on BMI Trajectory and Target Attainment: A Prospective Matched Cohort Study. Diabetes Obes Metab. 2026 May 31. doi: 10.1111/dom.70912. Online ahead of print.
PMID42219275via clinicaltrials gov reference derived

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.