Effects of semaglutide on heart health in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates how semaglutide, a medication known for its benefits in type 2 diabetes, affects cardiovascular function, kidney function, and insulin sensitivity in adults with type 1 diabetes. The study involves administering semaglutide or a placebo to participants aged 18-49 who have been diagnosed with type 1 diabetes and meet specific health criteria. The goal is to determine the efficacy of semaglutide in improving health outcomes for this population, as it is not currently FDA-approved for use in type 1 diabetes. The trial is considered experimental and aims to provide insights into potential new treatment options.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• University of Washington Medicine Diabetes Institute (UWMDI)
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Petter M Bjornstad, MD — University of Washington
• Study coordinator: Kyla Best
• Email: Kyla.Best@cuanschutz.edu
• Phone: 720-777-9500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.