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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

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

2

Recruiting sites

Enrollment

190

actual

Study population

Bariatric Surgery, Bariatric Surgery Candidate, Obesity / overweight

Key I/E criterion

BMI ≥35

Primary endpoint

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

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. 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

Study populations

Who this study enrolls

Bariatric SurgeryBariatric Surgery CandidateObesity / overweight

Eligibility

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
3
Glycemic / diabetes
2
Weight & body composition
1

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.