NCT04575844 · University of Virginia
Effects of Exercise and GLP-1 Agonism on Muscle Microvascular Perfusion and Insulin Action in Adults With Metabolic Syndrome
(ZQL008)
What this 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- HMG CoA reductase inhibitor
- Beta blocker
- Calcium channel blockers
- Alpha-adrenergic antagonist
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
Where
- Charlottesville, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations