Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Criteria

Inclusion Criteria:

• Age 18-40 years

• Antibody + T1D <30 years, ≥ 10 years duration

• Insulin pump or automated insulin delivery systems

• eGFR ≥ 45 ml/min/1.73m2

• Stable doses of drugs altering cardiovascular and renal function (e.g., ACEi, ARB, statins, diuretics)

• BMI 20-35 kg/m2

• Adequate contraceptive method for females

Exclusion Criteria:

• HbA1c >9%, recent DKA or hospitalization

• Congenital heart disease, anemia, diabetic retinopathy

• History/FH of medullary thyroid carcinoma, MEN2, pancreatitis

• Current/planned pregnancy or nursing

• Uncontrolled thyroid disease or 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

• Significant systemic illness such as cancer

• MRI or PAH contraindications, Iodine or GLP-1RA allergy