Diabetes Mellitus, Type 1
Conditions
Brief summary
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.
Interventions
Semaglutide injection
DRUGPlacebo
Semaglutide placebo injection
Sponsors
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-49 years * 1\) T1D diagnosis defined as positive T1D-associated antibody(ies) or 2) a clinical diagnosis of T1D plus insulin requirement since diagnosis * Insulin pump or automated insulin delivery systems * Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73m2 * Stable doses of drugs altering cardiovascular and renal function (e.g., Angiotensin-Converting Enzyme Inhibitor (ACEi), Angiotensin Receptor Blocker (ARB), statins, diuretics) * BMI 20-45 kg/m2 * Adequate contraceptive method for females
Exclusion criteria
* HbA1c \>9%, recent diabetic ketoacidosis (DKA) or hospitalization * Major congenital heart disease, anemia, severe non-proliferative retinopathy, proliferative retinopathy * History/family history of medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (MEN2), pancreatitis * Current/planned pregnancy or nursing * Uncontrolled thyroid disease or hypertension (HTN) (≥ 160/100 mm Hg despite optimal therapy) * Use of other non-insulin diabetes medications, insulin sensitizing medications, or systemic steroids in past 3 months * Use of atypical antipsychotics * Significant systemic illness such as cancer * Shellfish/iodine allergy (only exclusionary to iohexol clearance procedure) * MRI or PAH contraindications (only exclusionary to MRI and PAH procedures), GLP-1RA allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ascending Aortic Pulse Wave Velocity (AA PWV) | Baseline, month 8 | AA PWV is a measure of central arterial stiffness. A lower value indicates a better outcome. |
| Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV) | Baseline, month 8 | CF-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome. |
| Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV) | Baseline, month 8 | CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Sensitivity | Baseline, month 8 | 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. |
| Change in Renal Vascular Resistance (RVR) | Baseline, month 8 | RVR is a measure of mean arterial pressure to renal blood flow. A higher value indicates a worse outcome. |
Countries
United States
Contacts
CONTACTKyla Best
PRINCIPAL_INVESTIGATORPetter M Bjornstad, MD
University of Washington
PRINCIPAL_INVESTIGATORKristen Nadeau, MD, MS
University of Colorado, Denver
Outcome results
None listed