Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-30
SponsorYale University
About this trial
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
Qualifiers
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
Disqualifiers
Use of adjunctive diabetes therapies or anti-obesity medications (including any GLP-1 agonist) currently or within the past 6 months.
Insulin dosing <0.5 units/kg/day
Current psychiatric conditions impacting weight, including known eating disorders
Personal history of pancreatitis, renal impairment, or known liver disease other than non-alcoholic hepatic steatosis
Trial design
Treatments tested in this trial
- Semaglutide Pen Injector
- Placebo
Treatment groups
54 Participants
are divided into 2 treatment groupsLocations
1Yale Pediatric Diabetes Center, Adult and Children's Progam06520, New HavenConnecticut, United States
Sponsors and collaborators
Yale University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Novo Nordisk A/S
Collaborator
Source ClinicalTrials.gov