Health TrialsbyHealthPanel

Type 1 Diabetes Impacts of Semaglutide on Cardiovascular Outcomes

ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-49
SponsorUniversity of Colorado, Denver

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semaglutide Pen Injector

    Drug

    Semaglutide injection

  • Placebo

    Drug

    Semaglutide placebo injection

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SemaglutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Ascending Aortic Pulse Wave Velocity (AA PWV)

AA PWV is a measure of central arterial stiffness. A lower value indicates a better outcome.

Time frame
Baseline, month 8
2

Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV)

CF-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.

Time frame
Baseline, month 8
3

Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)

CR-PWV is a measure of peripheral arterial stiffness. A lower value indicates a better outcome.

Time frame
Baseline, month 8

Secondary outcomes

1

Change in Insulin Sensitivity

Insulin Sensitivity is a measure of how well the body responds insulin. A higher value indicates a better outcome; a lower value indicates a worse outcome.

Time frame
Baseline, month 8
2

Change in Renal Vascular Resistance (RVR)

RVR is a measure of mean arterial pressure to renal blood flow. A higher value indicates a worse outcome.

Time frame
Baseline, month 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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