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Recruiting
NCT06411210
Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Conditions: Diabetes type1, Obesity
Sex: All
Ages: 18 Years – 30 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 54
Sponsor: Yale University
Location: Yale Pediatric Diabetes Center, Adult and Children's Progam New Haven Connecticut
Summary
More than 40% of young adults with type 1 diabetes (T1D) also have overweight or obesity. Each of these diagnoses increase the risk of adverse cardiovascular events. GLP-1 analogues are anti-obesity medications that are cardioprotective in adults with type 2 diabetes, however evaluation of these agents in people with T1D has been limited to glycemic outcomes. Investigators aim to study the impact of GLP-1 analogue obesity treatment on markers of cardiometabolic risk in young adults with T1D and obesity.
Eligibility Criteria
Inclusion Criteria:
* Age 18-30 years with T1D whose BMI meets FDA approval criteria for anti-obesity pharmacotherapy (BMI ≥30 kg/m2 alone or BMI ≥27 kg/m2 with a weight-related comorbidity)
* Clinical diagnosis of T1D
* Diabetes duration diagnosed ≥ 12 months ago
* HbA1c ≤10% at screening and within the past 90 days
* Stable reported insulin dosing in the past 90 days (within 15%)
* Stable reported BMI in the past 90 days (within 5%)
* Ability to provide written informed consent before any trial-related activities
* Use of real-time continuous glucose monitoring and planned continued use
* Females and males of childbearing potential willing to use highly effective methods of contraception for at least 1 month prior to randomization and agreement to use such a method during study participation and for 2 months after the last dose of study medication administration: Combined estrogen-progestogen contraception including: oral, intravaginal, transdermal (patch), Progestogen-only contraception: oral, injectable or implantable, Placement of an intrauterine device or intrauterine system, Bilateral tubal occlusion (fallopian tubes are blocked), Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate), or Complete sexual abstinence from male-female sex)
* Stated willingness to comply with all study procedures, medication regimen, and availability for the duration of the study
* Participants cannot be randomized if any laboratory safety parameter at screening is outside the below extended laboratory ranges. For randomization, participants should have
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Source: ClinicalTrials.gov (NCT06411210). StuddyBuddy aggregates publicly available trial information.