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

Who is this study for? Adults with metabolic syndrome
What treatments are being studied? Liraglutide+Exercise training
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 60
Healthy Volunteers: t
View:

• 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.

• Meet 3 of 5 National Cholesterol Education Program Adult Treatment Panel III Metabolic Syndrome criteria:

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

⁃ Elevated triglycerides (≥150 mg/dl)

⁃ Reduced HDL-cholesterol (\<40mg/dl in men, \<50 mg/dl in women)

⁃ High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic)

⁃ Elevated fasting glucose (≥100 mg/dl)

⁃ Subject may participate if on the following drugs, provided the drug doses have been stable for at least 3 months.

⁃ Ace inhibitor

⁃ ARB

⁃ HMG CoA reductase inhibitor

⁃ Beta blocker

⁃ Calcium channel blockers

⁃ Alpha-adrenergic antagonist

⁃ Statin

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Lee Hartline, MEd
lmh9d@virginia.edu
434-924-5247
Backup
Linda Jahn, MEd
las6e@virginia.edu
434-924-1134
Time Frame
Start Date: 2020-11-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 80
Treatments
Experimental: Exercise Alone
24 weeks of treatment
Experimental: Liraglutide Alone
24 weeks of treatment
Experimental: Exercise + Liraglutide
24 weeks f treatment
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Leads: University of Virginia

This content was sourced from clinicaltrials.gov

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