| Trial ID: | L4872 |
| Source ID: | NCT05819138
|
| Associated Drug: |
Semaglutide Pen Injector
|
| Title: |
Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
|
| Acronym: |
T1-DISCO
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Semaglutide Pen Injector|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Ascending Aortic Pulse Wave Velocity (AA PWV), AA PWV is a measure of central arterial stiffness. A lower value indicates a better outcome., Baseline, month 8|Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV), CF-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome., Baseline, month 8|Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV), CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome., Baseline, month 8 | Secondary: Change in Insulin Sensitivity, Insulin Sensitivity is a measure of how well the body responds insulin. A higher value indicates a better outcome; a lower value indicates a worse outcome., Baseline, month 8|Change in Renal Vascular Resistance (RVR), RVR is a measure of mean arterial pressure to renal blood flow. A higher value indicates a worse outcome., Baseline, month 8
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver | Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2023-06-21
|
| Completion Date: |
2026-12
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-18
|
| Locations: |
University of Colorado Anschutz Medical Campus, Aurora, Colorado, 80045, United States|University of Washington Medicine Diabetes Institute (UWMDI), Seattle, Washington, 98109, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05819138
|
