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 groupsSponsors 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