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Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
NCT05819138 · University of Colorado, Denver
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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 criteria
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
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: triple
Age groups: adult
Timeline
Starts: 2023-06-21
Estimated completion: 2027-12-01
Last updated: 2026-03-04
Interventions
Drug: Semaglutide Pen InjectorDrug: Placebo
Primary outcomes
- • Change in Ascending Aortic Pulse Wave Velocity (AA PWV) (Baseline, month 8)
- • Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV) (Baseline, month 8)
- • Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV) (Baseline, month 8)
Sponsor
University of Colorado, Denver · other
With: National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactKyla Best · contact · Kyla.Best@cuanschutz.edu · 720-777-9500
InvestigatorPetter M Bjornstad, MD · principal_investigator, University of Washington
InvestigatorKristen Nadeau, MD, MS · principal_investigator, University of Colorado, Denver
All locations (2)
University of Colorado Anschutz Medical CampusRecruiting
Aurora, Colorado, United States
University of Washington Medicine Diabetes Institute (UWMDI)Recruiting
Seattle, Washington, United States