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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide group | Experimental | Participants will be in this group for up to 12 weeks. |
|
| Mediterranean diet group | Experimental | Participants will be in this group for up to 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in percentage of participants retained | The percentage of participants retained will be measured | Baseline, 12 weeks |
| Number of patients who adhere to diet measured by 24 hour dietary recall | Number of patients who adhere to diet measured by 24 hour dietary recall | Up to 12 weeks |
| Number of patients who adhere to medications measured by self report | Number of patients who adhere to medications measured by self report | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of calls completed | Number of calls completed. Calls will be made either on a phone or virtually using Zoom. | Up to 12 weeks |
| Number of dietary recall (ASA24) surveys completed | Number of dietary recall (ASA24) surveys completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Ioannou, MD | Contact | 305-243-2515 | s.ioannou@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Oriana Damas, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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|
| Mediterranean diet | Behavioral | 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. |
|
| Up to 12 weeks |
| Number of clinical symptom (HBI/CDAI) surveys completed | Number of clinical symptom (HBI/CDAI) surveys completed | Up to 12 weeks |
| Number of blood samples completed | Number of blood samples completed | Up to 12 weeks |
| Number of stool samples completed | Number of stool samples completed | Up to 12 weeks |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |