Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Description

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.

Conditions

Diabetes Mellitus, Type 1

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Study Overview

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Study Details

Study 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.

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

Condition
Diabetes Mellitus, Type 1
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Seattle

University of Washington Medicine Diabetes Institute (UWMDI), Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 49 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Petter M Bjornstad, MD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

Kristen Nadeau, MD, MS, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

Study Record Dates

2026-12