Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide Pen Injector, Placebo.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 1. Basic parameters: 18 years — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug Semaglutide Pen Injector
Semaglutide injection - Drug Placebo
Semaglutide placebo injection
Primary outcome measures
- Change in Ascending Aortic Pulse Wave Velocity (AA PWV) [Time frame: Baseline, month 8]
- Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV) [Time frame: Baseline, month 8]
- Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV) [Time frame: Baseline, month 8]
Secondary outcome measures (2)
- Change in Insulin Sensitivity [Time frame: Baseline, month 8]
- Change in Renal Vascular Resistance (RVR) [Time frame: Baseline, month 8]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Colorado Anschutz Medical Campus — Aurora
- University of Washington Medicine Diabetes Institute (UWMDI) — Seattle
Identifiers
NCT: NCT05819138 · 22-0794 · R01HL165433