Clinical trial NCT06774079: Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Crohn Disease
Keywords: inflammatory bowel disease
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in percentage of participants retained
timeFrame: Baseline, 12 weeks
measure: Number of patients who adhere to diet measured by 24 hour dietary recall
timeFrame: Up to 12 weeks
measure: Number of patients who adhere to medications measured by self report
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Number of calls completed
timeFrame: Up to 12 weeks
measure: Number of dietary recall (ASA24) surveys completed
timeFrame: Up to 12 weeks
measure: Number of clinical symptom (HBI/CDAI) surveys completed
timeFrame: Up to 12 weeks
measure: Number of blood samples completed
timeFrame: Up to 12 weeks
measure: Number of stool samples completed
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Oriana Damas, MD
role: PRINCIPAL_INVESTIGATOR
References: