Health TrialsbyHealthPanel

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

ConditionsDiabetes Mellitus, Type 1Endothelial Dysfunction
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-40
SponsorAdventHealth Translational Research Institute

About this trial

The investigators will test the hypothesis that, in adults with type 1 diabetes (T1D), glucagon-like peptide-1 receptor agonism (GLP-1RA, i.e. dulaglutide) enhances insulin-mediated skeletal muscle microvascular perfusion via attenuating endothelial oxidative stress and thereby improving endothelial function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of type 1 diabetes, duration > 5 years

Age 18-40 years

HbA1c < 8.5%

BMI 19-34.9 kg/m2

Disqualifiers

Pregnancy or currently breastfeeding

Smoking history within 6 months

History of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) as well as clinically significant cardiac arrhythmias or conduction disorders

Taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dulaglutide

    Drug

    GLP1-RA

  • Placebo

    Drug

    Saline placebo

Treatment groups

47 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: DulaglutideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Microvascular blood volume (MBV)

Insulin mediated change in muscle microvascular blood volume (MBV). A measure of microvascular nitric oxide dependent endothelial function

Time frame
At baseline and after 14 weeks of treatment.

Secondary outcomes

1

Brachial artery flow mediated dilation (FMD)

Post-occlusive percent (%) change in diameter. A measure of conduit artery nitric oxide-dependent endothelial function.

Time frame
At baseline and after 14 weeks of treatment
2

Glucose infusion rate (GIR)

Mean GIR over the final 30 minutes of euglycemic insulin clamp; a measure of insulin sensitivity

Time frame
At baseline and after 14 weeks of treatment
3

Cardiorespiratory fitness, maximum consumption of oxygen (VO2max)

Assessed by cycle ergometer exercise testing.

Time frame
At baseline and after 14 weeks of treatment
4

Skeletal muscle oxygenation, deoxyhemoglobin (HHb)

Assessed by frequency domain multi-distance near-infrared spectroscopy (NIRS) monitor at the quadriceps muscle

Time frame
At baseline and after 14 weeks of treatment. Measured before and after insulin clamp.

Other outcomes

Sponsors and contacts

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

AdventHealth Translational Research Institute

Lead sponsor

Source ClinicalTrials.gov
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