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HomeTrials › NCT04575844

Other · Phase 4 · Recruiting now

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

NCT04575844 · Sponsor: University of Virginia

What this trial means for you

This study is recruiting now at 1 US site. It's studying Liraglutide, Liraglutide + Exercise training for metabolic syndrome.

Who can joinAll sexes, 21 Years – 60 Years
Healthy volunteersAccepted
What you'd takeLiraglutide, Liraglutide + Exercise training
Study length~6.5 years overall
Planned participants80
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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 sites by state

Virginia

  • University of Virginia — Charlottesville · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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