Recruiting

Exercise & GLP-1 Agonism

Sponsor:

University of Virginia

Code:

NCT04575844

Conditions

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

Interventions

Liraglutide

Exercise training

Liraglutide + Exercise training

Study Details

Brief 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.

Conditions

Metabolic Syndrome

Study ID

NCT04575844

Start date

Nov 1, 2020

Status verified date

May, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise Alone

24 weeks of treatment

experimental: Liraglutide Alone

24 weeks of treatment

experimental: Exercise + Liraglutide

24 weeks f treatment

Interventions

Liraglutide

24 weeks of Liraglutide

Exercise training

24 weeks of Exercise training

Liraglutide + Exercise training

24 weeks of Liraglutide + Exercise training

Primary outcome measure

  • Microvascular Blood Volume - change from baseline [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Lee Hartline, MEd

434-924-5247lmh9d@virginia.edu

Linda Jahn, MEd

434-924-1134las6e@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22906

Contacts

Zhenqi Liu, MD

434-243-2603zl3e@virginia.edu

Eugene Barrett, MD, PhD

434-924-1175ejb8x@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-05-06.