Effects of Exercise and GLP-1 Agonism on Muscle Microvascular Perfusion and Insulin Action in Adults With Metabolic Syndrome

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21-60
SponsorUniversity of Virginia

About this trial

The primary objective of this study is to examine whether exercise training alone, liraglutide treatment alone or exercise training plus liraglutide treatment increases cardiac and skeletal muscle microvascular blood volume, improves vascular function of the conduit vessels, and enhances insulin's metabolic action in humans with Metabolic Syndrome. Subjects will be randomized to one of the 4 groups: control, exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 24 weeks of intervention.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female ≥21 and ≤60 years old.

Body mass index >25 and ≤35 kg/m2 and is weight stable (<5 kg weight change in the past 6 months). BMI is limited to ≤35 kg/m2 for easier vascular access and cardiac imaging.

Increased waist circumference (≥102 cm in men; ≥88 cm in women)

Elevated triglycerides (≥150 mg/dl)

Disqualifiers

A diagnosis of any type of diabetes or history of diabetes medication use

Recently active (>20 min of moderate/high intensity exercise, 2 times/week)

Subjects who are smokers or who have quit smoking <5 years

Subjects with hypertriglyceridemia (>400 mg/dl) or hypercholesterolemia (>260 mg/dl)

Trial design

Design model

Factorial

Treatments tested in this trial

  • Liraglutide

    Drug

    24 weeks of Liraglutide

  • Exercise training

    Other intervention

    24 weeks of Exercise training

  • Liraglutide + Exercise training

    Drug

    24 weeks of Liraglutide + Exercise training

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Exercise AloneExperimental treatment 1 intervention
Group B: Liraglutide AloneExperimental treatment 1 intervention
Group C: Exercise + LiraglutideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Microvascular Blood Volume - change from baseline

measured at baseline and 24 weeks

Time frame
24 weeks

Secondary outcomes

1

Augmentation Index - change from baseline

measured at baseline and 24 weeks

Time frame
24 weeks
2

Flow Mediated Dilation

measured at baseline and 24 weeks

Time frame
24 weeks
3

Pulse Wave Velocity

measured at baseline and 24 weeks

Time frame
24 weeks
4

Post Ischemic Flow Velocity - change from baseline

measured at baseline and 24 weeks

Time frame
24weeks

Other outcomes

Sponsors and contacts

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

University of Virginia

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator