What this study is
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.
What's being tested
- Liraglutide
Intervention · DRUG
24 weeks of Liraglutide
- Exercise training
Intervention · OTHER
24 weeks of Exercise training
- Liraglutide + Exercise training
Intervention · DRUG
24 weeks of Liraglutide + Exercise training
Study details
- Sponsor
- University of Virginia
- Conditions
- Metabolic Syndrome
- Enrolling
- 80 people
- Starts
- 2020-11-01
- Est. completion
- 2027-04-30
- Design
- Open-label, randomized, factorial, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 60 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Virginia
Charlottesville, Virginia, United States
- Zhenqi Liu, MD · Contact434-243-2603zl3e@virginia.edu
- Eugene Barrett, MD, PhD · Contact434-924-1175ejb8x@virginia.edu
Recruiting
Study team
Sponsor
University of Virginia
Study ID 200065
Principal investigator
Zhenqi Liu, MD
Division of Endocrinology and Metabolism, University of Virginia
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.