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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 30
Healthy Volunteers: f
View:

• 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

• Stable reported insulin dosing in the past 90 days (within 15%)

• Stable reported BMI in the past 90 days (within 5%)

• Ability to provide written informed consent before any trial-related activities

• Use of real-time continuous glucose monitoring and planned continued use

• Females and males of childbearing potential willing to use highly effective methods of contraception for at least 1 month prior to randomization and agreement to use such a method during study participation and for 2 months after the last dose of study medication administration: Combined estrogen-progestogen contraception including: oral, intravaginal, transdermal (patch), Progestogen-only contraception: oral, injectable or implantable, Placement of an intrauterine device or intrauterine system, Bilateral tubal occlusion (fallopian tubes are blocked), Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate), or Complete sexual abstinence from male-female sex)

• Stated willingness to comply with all study procedures, medication regimen, and availability for the duration of the study

• Participants cannot be randomized if any laboratory safety parameter at screening is outside the below extended laboratory ranges. For randomization, participants should have

‣ Creatinine \<1.0mg

⁃ Triglycerides (\<400 mg/dl)

⁃ ALT \<3.5 times the upper normal limit (UNL)

Locations
United States
Connecticut
Yale Pediatric Diabetes Center, Adult and Children's Progam
RECRUITING
New Haven
Contact Information
Primary
Rehema Mtawali
rehema.mtawali@yale.edu
203-785-7455
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 54
Treatments
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.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Novo Nordisk A/S
Leads: Yale University

This content was sourced from clinicaltrials.gov