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

University of Miami

Status and phase: Enrolling; Phase 4

Conditions: Crohn Disease

Treatments: Drug: Tirzepatide; Behavioral: Mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06774079

20240982

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Tirzepatide group

Experimental group

Description:

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

Treatment:

Behavioral: Mediterranean diet

Drug: Tirzepatide

Mediterranean diet group

Experimental group

Description:

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

Treatment:

Behavioral: Mediterranean diet