Crohn Disease
Conditions
Keywords
inflammatory bowel disease
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.
Interventions
DRUGTirzepatide
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.
BEHAVIORALMediterranean 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.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in percentage of participants retained | Baseline, 12 weeks | The percentage of participants retained will be measured |
| Number of patients who adhere to diet measured by 24 hour dietary recall | Up to 12 weeks | Number of patients who adhere to diet measured by 24 hour dietary recall |
| Number of patients who adhere to medications measured by self report | Up to 12 weeks | Number of patients who adhere to medications measured by self report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of calls completed | Up to 12 weeks | Number of calls completed. Calls will be made either on a phone or virtually using Zoom. |
| Number of dietary recall (ASA24) surveys completed | Up to 12 weeks | Number of dietary recall (ASA24) surveys completed |
| Number of clinical symptom (HBI/CDAI) surveys completed | Up to 12 weeks | Number of clinical symptom (HBI/CDAI) surveys completed |
| Number of blood samples completed | Up to 12 weeks | Number of blood samples completed |
| Number of stool samples completed | Up to 12 weeks | Number of stool samples completed |
Countries
United States
Contacts
CONTACTStephanie Ioannou, MD
PRINCIPAL_INVESTIGATOROriana Damas, MD
University of Miami
Outcome results
None listed