RecruitingPhase 3NCT05819138

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Sponsor

University of Colorado, Denver

Enrollment

60 participants

Start Date

Jun 21, 2023

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

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.

Eligibility

Min Age: 18 YearsMax Age: 49 Years

Inclusion Criteria7

Age 18-49 years
\) 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 Criteria10

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