REFORM

Recruiting

Comparison of Body Composition Changes With Weight Loss Interventions

Conduct of the REsponses in Function and Outcomes From RYGB vs. Medication Study (REFORM) Study by Research Coordinators

Lead sponsor

Vanderbilt University Medical Center

Assets

GLP-1 / incretin class catch-all / Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Bariatric Surgery, Obesity / overweight

Key I/E criterion

•BMI 35-60

Primary endpoints

•Lean mass•PGI, change•Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire

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 IDNCT07115069

Org study ID251035

Secondary IDU16066Vanderbilt University Medical Center

Timeline

Milestones

Study start2025-08-09actual

Study first posted2025-08-11actual

Last update posted2025-10-21actual

Primary completion2026-09estimated (month precision)

Study completion2027-01estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide Tirzepatide

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweight

Eligibility

Who can enroll

Minimum age21 Years

Maximum age65 Years

SexAll

Sampling methodNon probability sample

Study population text

Participants seeking medical or surgical weight loss for class III obesity

Inclusion criteria

•BMI ≥35 and ≤60

•Primary weight loss surgery (gastric bypass), or

•Medical weight loss with GLP1RAs (Semaglutide or Tirzepatide)

Exclusion criteria

•Revisional gastric bypass (e.g. sleeve to bypass),

•<3 months of continuous use of GLP1RA,

•Type 1 Diabetes,

•Myocardial Infarction,

•Unstable Angina or Heart Failure,

•Stroke

•Solid organ transplantation,

•Systemic glucocorticoid prior 28 days,

•Uncontrolled Hypertension, (Systolic > 150, Diastolic > 90)

•Untreated Hyperthyroidism

•Chronic Kidney Disease (EGFR < 60).

Endpoints (10)

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

Weight & body composition

Patient-reported / QoL

Weight & body composition

7 endpoints

Primary/protocol endpoint

Skeletal Muscle Loss

Time frame:6 months

Lean mass

percent change from baseline, improvement

Primary/protocol endpoint

Skeletal Muscle Loss

Time frame:12 months

Lean mass

percent change from baseline, improvement

Secondary/protocol endpoint

Incidence of 10% weight loss

Time frame:6 months

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Incidence of 10% weight loss

Time frame:12 months

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Incidence of 15% weight loss

Time frame:6 months

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Incidence of 15% weight loss

Time frame:12 months

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Grip Strength

Time frame:3, 6, and 12 months

change from baseline, improvement

Patient-reported / QoL

3 endpoints

Primary/protocol endpoint

Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire

Time frame:6 months

PGI, change

descriptive, improvement

Primary/protocol endpoint

Patient Assessment of Upper Gastrointestinal Disorders Symptoms Questionnaire

Time frame:12 months

descriptive, improvement

Secondary/protocol endpoint

PAGI-SYM sub-scale scores

Time frame:6 months

descriptive, improvement

Publications (3)

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

Weighty matters: Ozempic, autonomy and the ethics of health reform.
Journal of medical ethics2026 Feb 27PMID40921625doi:10.1136/jme-2025-111117via pubmed acronym asset candidate
Fixing the food environment: beyond weight-loss drugs.
Public health nutrition2026 Feb 6PMID41645430doi:10.1017/S1368980026101839via pubmed acronym asset candidate
Income disparities and accessibility to Semaglutide: implications for diabetes management and policy reform.
International journal for quality in health care : journal of the International Society for Quality in Health Care2026 Jan 10PMID41437637doi:10.1093/intqhc/mzaf131via pubmed acronym asset candidate

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.