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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06411210
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 16, 2024
Status verified
Apr 2025
Primary completion
Apr 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Semaglutide
    Participants in this arm will receive semaglutide (escalated to 2.4mg or max tolerated dose) weekly for 12 months. Then a 4 week wean period plus 2 weeks as needed insulin titration.
  • Placebo Comparator: Placebo
    Participants in this arm will receive a matched placebo weekly for 12 months. Then a 4 week wean period plus 2 weeks as needed insulin titration.

Primary Outcome Measure

Change in VAT/(VAT+SAT) from baseline to 12 months [ Time Frame: baseline and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Pediatric Diabetes Center, Adult and Children's ProgamNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Yale Pediatric Diabetes Center, Adult and Children's Progam· New Haven, CT

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