Effects of exercise and medication on blood flow and insulin action in adults with metabolic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to investigate the impact of exercise training, liraglutide treatment, and their combination on muscle microvascular blood volume and insulin action in adults diagnosed with metabolic syndrome. Participants will be randomly assigned to one of four groups: a control group, an exercise training group, a liraglutide treatment group, or a combination of both interventions. The study will assess changes in vascular function and insulin response after a 24-week intervention period. The hypothesis is that both liraglutide and exercise will enhance microvascular insulin responses and that their combination will yield the most significant benefits.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Zhenqi Liu, MD — Division of Endocrinology and Metabolism, University of Virginia
• Study coordinator: Lee Hartline, MEd
• Email: lmh9d@virginia.edu
• Phone: 434-924-5247

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.