Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes
Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The investigators will test the hypothesis that, in adults with type 1 diabetes (T1D), glucagon-like peptide-1 receptor agonism (GLP-1RA, i.e. dulaglutide) and exercise training each enhance insulin-mediated skeletal muscle microvascular perfusion via attenuating endothelial oxidative stress and thereby improving endothelial function.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:
• History of type 1 diabetes, duration \> 5 years
• Age 18-40 years
• HbA1c \< 8.5%
• BMI 19-34.9 kg/m2
• Using insulin for diabetes treatment only (multiple daily injections or insulin pump with or without sensor augmentation)
• On stable regimen of non-diabetic medications for the last 6 months
• All screening labs within normal limits or not clinically significant
• C-peptide \<0.6 ng/ml
Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Kaitlin Love, MD
KML2W@hscmail.mcc.virginia.edu
434-924-9651
Backup
Lee Hartline, MEd
lmh9d@virginia.edu
Time Frame
Start Date: 2023-10-05
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 64
Treatments
Placebo_comparator: Placebo
Saline subcutaneous injection, volume matched to dulaglutide, i.e. 0.5 mL weekly for 14 weeks
Active_comparator: Dulaglutide
Dulaglutide (0.75 mg/0.5 mL weekly for 2 weeks, then 1.5 mg/0.5 mL weekly for 12 weeks) subcutaneous injection
Active_comparator: Exercise training
Supervised high intensity interval training on a stationary bicycle will be conducted 3 days per week for 14 weeks. Participants will warm up at low intensity for 3 min then repeat 1-min bouts of 100% peak power output followed by 1-min recovery at 50 W. Training will start with 6 intervals per session, increasing by 2 intervals every 2 weeks. Sessions will end with a 10-min cool-down.
Related Therapeutic Areas
Sponsors
Leads: University of Virginia