Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL165433 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
This trial plans to learn more about the effects of a medication, semaglutide, on cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. This medication has been effective in reducing cardiovascular disease and diabetic kidney disease and improving glucose control and BMI in adults with type 2 diabetes. This study aims to look at how well the medication works in people with type 1 diabetes. Semaglutide is not approved by the FDA to be used in this way. These procedures are considered to be experimental.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | Participants will receive 0.25 mg once weekly semaglutide injection for 4 weeks. Participants will receive 0.50 mg once weekly semaglutide injection for 4 weeks. Participants will receive 1.0 mg once weekly semaglutide injection for 6 months. |
|
| Placebo | Placebo Comparator | Participants will receive 0.25 mg once weekly placebo injection for 4 weeks. Participants will receive 0.50 mg once weekly placebo injection for 4 weeks. Participants will receive 1.0 mg once weekly placebo injection for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide Pen Injector | Drug | Semaglutide injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyla Best | Contact | 720-777-9500 | Kyla.Best@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Petter M Bjornstad, MD | University of Washington | Principal Investigator |
| Kristen Nadeau, MD, MS | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Semaglutide placebo injection |
|
RVR is a measure of mean arterial pressure to renal blood flow. A higher value indicates a worse outcome.
| Baseline, month 8 |
| University of Washington Medicine Diabetes Institute (UWMDI) | Recruiting | Seattle | Washington | 98109 | United States |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |