Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
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
University of Miami
24 participants
Mar 5, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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 Criteria12
- 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
Interventions
Patients in this arm will receive tirzepatide starting at 2.5 mg subcutaneous (SC) weekly for 4 weeks, then increase to 5 mg SC weekly for 4 weeks and then 7.5 mg SC weekly for the last 4 weeks of the intervention period. Place of injection includes abdomen, thigh, or upper arm.
The diet is comprised of a content of 25-30 grams of fiber per day (from fruits, vegetables, whole grains) that is low in animal protein and minimally processing of foods The diet arm will receive dietary guidance from our dietician on weekly 30-minute guided sessions. Participants will be encouraged to adhere to the diet for up to three meals per day for the duration of the study.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06774079