Clinical trial NCT05819138: Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
Official title: Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Primary outcomes:
measure: Change in Ascending Aortic Pulse Wave Velocity (AA PWV)
timeFrame: Baseline, month 8
measure: Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)
timeFrame: Baseline, month 8
measure: Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)
timeFrame: Baseline, month 8
Secondary outcomes:
measure: Change in Insulin Sensitivity
timeFrame: Baseline, month 8
measure: Change in Renal Vascular Resistance (RVR)
timeFrame: Baseline, month 8
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Seattle
country: United States
facility: University of Washington Medicine Diabetes Institute (UWMDI)
state: Washington
Study officials:
affiliation: University of Colorado, Denver
name: Petter M Bjornstad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Kristen Nadeau, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: