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

Phase 4RecruitingNCT06774079

University of Miami24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Crohn Disease

Interventions

TirzepatideDRUG

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 dietBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Change in percentage of participants retained

The percentage of participants retained will be measured

Time frame: Baseline, 12 weeks

Number of patients who adhere to diet measured by 24 hour dietary recall

Time frame: Up to 12 weeks

Number of patients who adhere to medications measured by self report

Time frame: Up to 12 weeks

Secondary Outcomes

Number of calls completed

Number of calls completed. Calls will be made either on a phone or virtually using Zoom.

Time frame: Up to 12 weeks

Number of dietary recall (ASA24) surveys completed

Time frame: Up to 12 weeks

Number of clinical symptom (HBI/CDAI) surveys completed

Time frame: Up to 12 weeks

Number of blood samples completed

Time frame: Up to 12 weeks

Number of stool samples completed

Time frame: Up to 12 weeks

Central Contacts

Stephanie Ioannou, MD

CONTACT

305-243-2515 s.ioannou@med.miami.edu

Data from ClinicalTrials.gov

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