NCT06411210

Obesity Complicating Type 1 Diabetes: GLP-1 Analogue Anti-obesity Treatment

Obesity Complicating Type 1 Diabetes in Young Adults: Physiology and Impact of GLP-1 Analogue Anti-obesity Treatment on Cardiometabolic Risk Factors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This proposal will address critical knowledge gaps of understanding potential salutary effects of GLP-1 analogue anti-obesity treatment with weekly semaglutide 2.4 mg on cardiometabolic risk factors in young adults with T1D and obesity, the group of people with T1D at greatest risk for future cardiovascular disease. Investigators aim to examine the impact of 12 months of treatment with weekly semaglutide 2.4 mg compared to placebo on abdominal adipose tissue distribution, glucose metabolism and postprandial atherosclerotic lipoproteins in young people with T1D and obesity. This is a single-center, parallel group, double-blinded, placebo controlled, randomized clinical trial. After informed consent procedures, participants will complete four assessments: 1) Abdominal MRI to evaluate abdominal adipose partitioning, 2) Euglycemic hyperinsulinemic clamp with isotope tracer enhancement to evaluate gluconeogenesis and glucose, glycerol, and b-hydroxybutyrate turnover to assess measures of insulin resistance, 3) DEXA scan to evaluate total body composition, and 4) a High-fat mixed meal tolerance test to evaluate postprandial lipemia. After completing these baseline measures, participants will be randomized in a 2:1 ratio to receive weekly injected semaglutide (escalated to 2.4 mg or maximum tolerated dose) or placebo to treat obesity for 52 weeks. At 52 weeks, participants will repeat the baseline tests. They will then complete a wean off of study drug (up to 4 weeks) and 2 weeks of additional monitoring for insulin titration.

Conditions

• Diabetes type1
• Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide Pen Injector	Escalated to 2.4mg or max tolerated dose
DRUG	Placebo	Matched placebo.

Timeline

• Start date: 2024-07-16
• Primary completion: 2028-04-30
• Completion: 2028-06-30
• First posted: 2024-05-13
• Last updated: 2025-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study