Study S001010

A Randomized Clinical Trial to Determine the Effect of Dual Glucose-dependent Insulinotropic Polypeptide (GIP)/GLP-1 Receptor Agonist-mediated Weight Loss and Diet on Crohn's Disease Clinical Response: a Pilot Study

ClinicalTrials.gov record

Registration

Registration: NCT06774079
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: SINGLE
Status: RECRUITING
Enrollment: 24
Start: 2025-03-05
Primary completion: 2027-03-05
Lead sponsor: University of Miami
Conditions: Crohn Disease
Interventions: DRUG:Tirzepatide; BEHAVIORAL:Mediterranean diet
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Change in percentage of participants retained [Baseline, 12 weeks]
Number of patients who adhere to diet measured by 24 hour dietary recall [Up to 12 weeks]
Number of patients who adhere to medications measured by self report [Up to 12 weeks]

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