Actively Recruiting
Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Led by Yale University · Updated on 2025-05-02
54
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-30 years with type 1 diabetes and BMI meeting FDA criteria for anti-obesity treatment (BMI 6530 kg/m2 alone or BMI 6527 kg/m2 with weight-related comorbidity)
- Clinical diagnosis of type 1 diabetes
- Diabetes diagnosed at least 12 months ago
- HbA1c 10% or less at screening and within past 90 days
- Stable insulin dosing (within 15%) over past 90 days
- Stable BMI (within 5%) over past 90 days
- Ability to provide written informed consent
- Use of real-time continuous glucose monitoring and planned continued use
- Willingness to use highly effective contraception if of childbearing potential before and during study and for 2 months after last dose
- Willingness to comply with all study procedures and medication regimen
- Normal lab safety parameters at screening: creatinine <1.0 mg/dl, triglycerides <400 mg/dl, ALT <3.5 times upper normal limit
You will not qualify if you...
- Use of adjunctive diabetes therapies or anti-obesity medications (including any GLP-1 agonist) currently or within past 6 months
- Insulin dose less than 0.5 units/kg/day
- Current psychiatric conditions affecting weight, including known eating disorders
- Personal history of pancreatitis, renal impairment, or known liver disease other than non-alcoholic hepatic steatosis
- Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia Type 2
- Allergy to semaglutide or related products
- Use of lipid-lowering medications other than statins and omega-3
- Previous randomization in this trial
- Pregnant, breastfeeding, intending pregnancy, or not using adequate contraception
- Diabetic ketoacidosis in past 6 months
- MRI safety contraindications or claustrophobia
- Anemia or medical conditions affecting HbA1c or participation
- Treatment with investigational drug within past 1 month
- PHQ-9 score >15 or recent suicidal ideation or attempts
- Corn allergy
- Severe hypoglycemia requiring hospitalization in past 3 months
- Clinically significant gastroparesis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yale Pediatric Diabetes Center, Adult and Children's Progam
New Haven, Connecticut, United States, 06520
Actively Recruiting
Research Team
R
Rehema Mtawali
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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