Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Phase 3RecruitingNCT05819138

University of Colorado, Denver60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Semaglutide Pen Injector

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

RECRUITING

University of Washington Medicine Diabetes Institute (UWMDI)

Seattle, Washington, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, month 8

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline, month 8

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts