RECRUITING

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

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Conditions

Crohn Diseaseinflammatory bowel disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-03-05
Study Completion:2026-03-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06774079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients (≥18 years old)
  2. * Confirmed diagnosis of Crohn's disease
  3. * 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)
  4. * BMI ≥ 27 kg/m2
  5. * Patients will be on stable doses of medical therapy (anti-tumor necrosis factor (TNF) alpha blockers)
  1. * Patients under 18 years of age
  2. * Patients with ulcerative colitis
  3. * Patients with infectious colitis
  4. * BMI\<27 kg/m2
  5. * Patients with type 1 or type 2 diabetes
  6. * 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
  7. * Patients already on GIP/GLP-1 RA therapy
  8. * Patients with the following chronic symptoms: severe constipation, nausea, and/or vomiting
  9. * Patients with the following medical history: small bowel obstruction in the last year, intestinal stricture, known or suspected diagnosis of gastroparesis
  10. * Adults unable to consent
  11. * Pregnant patients (will be confirmed via a pregnancy test)
  12. * Prisoners

Contacts and Locations

Study Contact

Stephanie Ioannou, MD
CONTACT
305-243-2515
s.ioannou@med.miami.edu

Principal Investigator

Oriana Damas, MD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Oriana Damas, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-05
Study Completion Date2026-03-05

Study Record Updates

Study Start Date2025-03-05
Study Completion Date2026-03-05

Terms related to this study

Keywords Provided by Researchers

  • inflammatory bowel disease

Additional Relevant MeSH Terms

  • Crohn Disease