Status:
UNKNOWN
Interest of GLP1 Analogues in Overweight Type 2 Diabetic Patients With Chronic Inflammatory Bowel Disease
Lead Sponsor:
Fondation Hôpital Saint-Joseph
Conditions:
Inflammatory Bowel Diseases
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The risk of type 2 diabetes appears to be higher in patients with chronic inflammatory diseases, including chronic inflammatory bowel disease (IBD). IBD is a group of inflammatory diseases that includ...
Eligibility Criteria
Inclusion
- Patients between 18 and 75 years of age
- Patients with inflammatory bowel disease (Crohn's disease (CD) or ulcerative colitis (UC))
- Patient with poorly controlled type 2 diabetes (defined as deviation from the set glycemic target of more than 1% HbA1c)
- Patient with a BMI ≥ 25 kg/m2
- For women of childbearing age: effective contraception\* during treatment and up to 5 weeks after discontinuation
- \* Any contraceptive method used regularly and appropriately that has a low failure rate (i.e., less than 1% per year)
- Patient enrolled in a health insurance plan
- Francophone patient
- Patient with free, informed, written consent
- Exclusion Criteria:
- Patient with a personal or family history of medullary thyroid cancer
- Patient with an active cancer
- Patient with a history of acute or chronic pancreatitis
- Patients with a history of hypersensitivity to GLP1 analogues (or to any other component of the product)
- Patient with a history of severe GI intolerance to GLP-1 receptor agonists
- Patient already included in a risky interventional research protocol (RIPH1)
- Pregnant or breastfeeding women
- Patients with congestive heart failure New York Heart Association (NYHA) class IV
- Patient with end-stage renal disease
- Patients with clinically significant sustained elevation of resting heart rate
- Patient with anti-GAD antibodies in a previous workup at inclusion
- Patient under guardianship or curatorship
- Patient under court protection
- Patient deprived of liberty
Exclusion
Key Trial Info
Start Date :
January 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05196958
Start Date
January 25 2022
End Date
December 31 2024
Last Update
March 7 2023
Active Locations (1)
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1
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014