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RecruitingAccepts healthy volunteersPhase 4

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

University of Virginia · with National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT04575844

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–60 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
80
US sites recruiting
1
Study start
November 1, 2020
Record last updated
May 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Liraglutide; Exercise training; Liraglutide + Exercise training

Conditions: Metabolic Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)
  • Subjects with BP>160/90
  • Subjects with a history of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or malignancy
  • Pregnant (as evidenced by positive pregnancy test) or nursing women
  • Subjects with contraindications to participation in an exercise training program
  • Allergic to perflutren
  • A prior use of Liraglutide

Recruiting US locations

  • University of Virginia

    Charlottesville, VA 22906

    Site contact: Zhenqi Liu, MD · 434-243-2603 · zl3e@virginia.edu

Study contacts (from the official record)

  • Lee Hartline, MEd · 434-924-5247 · lmh9d@virginia.edu
  • Linda Jahn, MEd · 434-924-1134 · las6e@virginia.edu
Effects of Exercise and GLP-1 Agonism on Muscle Microvascular… (NCT04575844) | Bored Studies