Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: inflammation, rheumatologic
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; BMI ≥27 required; conditions: Crohn Disease
- Interventions
- Tirzepatide; Mediterranean diet
- Conditions
- Crohn Disease
- Phase and size
- Phase 4 · 24 participants
- Dates
- Start 2025-03-05
Primary completion 2027-03-05 - Sponsor
- University of Miami (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change in percentage of participants retainedBaseline, 12 weeks
- Number of patients who adhere to diet measured by 24 hour dietary recallUp to 12 weeks
- Number of patients who adhere to medications measured by self reportUp to 12 weeks
02Eligibility
Who can take part
Inclusion Criteria: * Adult patients (≥18 years old) * Confirmed diagnosis of Crohn's disease * Mildly active disease, defined by clinical symptoms using the Harvey Bradshaw Index (HBI) score between 5 and 7 (the HBI is a continuous score ranging from 0-16 where \<4 is considered remission) * BMI ≥ 27 kg/m2 * Patients will be on stable doses of medical therapy (anti-tumor necrosis factor (TNF) alpha blockers) Exclusion Criteria: * Patients under 18 years of age * Patients with ulcerative colitis * Patients with infectious colitis * BMI\<27 kg/m2 * Patients with type 1 or type 2 diabetes * Contraindications to a GIP/GLP-1 RA, including patients with a personal or family history of medullary thyroid cancer or in patients with Multiple Endocrine Neoplasia syndrome type 2 * Patients already on GIP/GLP-1 RA therapy * Patients with the following chronic symptoms: severe constipation, nausea, and/or vomiting * Patients with the following medical history: small bowel obstruction in the last year, intestinal stricture, known or suspected diagnosis of gastroparesis * Adults unable to consent * Pregnant patients (will be confirmed via a pregnancy test) * Prisoners
03Change log
Registry changes
No changes recorded since the trial was added.