| Trial ID: | L6232 |
| Source ID: | NCT05478707
|
| Associated Drug: |
Dulaglutide
|
| Title: |
Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes
|
| Acronym: |
KML002
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1|Endothelial Dysfunction
|
| Interventions: |
DRUG: Dulaglutide|DRUG: Placebo|BEHAVIORAL: exercise training
|
| Outcome Measures: |
Primary: Microvascular blood volume (MBV), Insulin mediated change in muscle microvascular blood volume (MBV). A measure of microvascular nitric oxide dependent endothelial function, At baseline and after 14 weeks of treatment. | Secondary: Brachial artery flow mediated dilation (FMD), Post-occlusive percent (%) change in diameter. A measure of conduit artery nitric oxide-dependent endothelial function., At baseline and after 14 weeks of treatment|Glucose infusion rate (GIR), Mean GIR over the final 30 minutes of euglycemic insulin clamp; a measure of insulin sensitivity, At baseline and after 14 weeks of treatment|Cardiorespiratory fitness, maximum consumption of oxygen (VO2max), Assessed by cycle ergometer exercise testing., At baseline and after 14 weeks of treatment|Skeletal muscle oxygenation, deoxyhemoglobin (HHb), Assessed by frequency domain multi-distance near-infrared spectroscopy (NIRS) monitor at the quadriceps muscle, At baseline and after 14 weeks of treatment. Measured before and after insulin clamp.
|
| Sponsor/Collaborators: |
Sponsor: University of Virginia
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2023-10-05
|
| Completion Date: |
2027-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-12
|
| Locations: |
University of Virginia, Charlottesville, Virginia, 22908, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05478707
|
