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 volunteersQualifiers
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
Factorial
Treatments tested in this trial
Liraglutide
Drug24 weeks of Liraglutide
Exercise training
Other intervention24 weeks of Exercise training
Liraglutide + Exercise training
Drug24 weeks of Liraglutide + Exercise training
Treatment groups
Trial outcomes
Primary outcomes
Microvascular Blood Volume - change from baseline
measured at baseline and 24 weeks
Secondary outcomes
Augmentation Index - change from baseline
measured at baseline and 24 weeks
Flow Mediated Dilation
measured at baseline and 24 weeks
Pulse Wave Velocity
measured at baseline and 24 weeks
Post Ischemic Flow Velocity - change from baseline
measured at baseline and 24 weeks
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