Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients

NCT ID: NCT06774079

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-05
• Study Completion Date: 2026-03-05

Brief 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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Tirzepatide group

Participants will be in this group for up to 12 weeks.

Group Type: EXPERIMENTAL

Tirzepatide

Intervention Type: DRUG

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.

Mediterranean diet

Intervention Type: BEHAVIORAL

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.

Mediterranean diet group

Participants will be in this group for up to 12 weeks.

Group Type: EXPERIMENTAL

Mediterranean diet

Intervention Type: BEHAVIORAL

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.

Interventions

Tirzepatide

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.

Intervention Type: DRUG

Mediterranean diet

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Oriana Mazorra Damas

Associate Professor of Clinical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oriana Damas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephanie Ioannou, MD

Role: CONTACT

s.ioannou@med.miami.edu

305-243-2515

Facility Contacts

Michael Mijares, CRC

Role: primary

mmijares74@med.miami.edu

305-243-6405

Other Identifiers

20240982

Identifier Type: -

Identifier Source: org_study_id