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Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
NCT06774079 · University of Miami
In plain English
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Official title
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
About this study
The purpose of this study is to use diet and an injectable medication called tirzepatide (Zepbound) glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist (GIP-GLP-1 RA) medication as adjunctive therapy (another treatment used together with the primary treatment) for Crohn's disease patients with mild disease who are on stable doses of biologic medication (infliximab or adalimumab) and who have a body mass index (BMI) of at least 27.
Eligibility criteria
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
Study design
Enrollment target: 24 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-03-05
Estimated completion: 2027-03-05
Last updated: 2026-03-30
Interventions
Drug: TirzepatideBehavioral: Mediterranean diet
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)
Sponsor
University of Miami · other
Contacts & investigators
ContactStephanie Ioannou, MD · contact · s.ioannou@med.miami.edu · 305-243-2515
InvestigatorOriana Damas, MD · principal_investigator, University of Miami
All locations (1)
University of MiamiRecruiting
Miami, Florida, United States