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

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

This study is testing whether exercise, a diabetes medication called liraglutide, or a mix of both can improve blood flow and insulin function in adults with metabolic syndrome.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 21 Years to 60 Years
• Sex: All
• Sponsor: University of Virginia (Academic / other)
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT04575844 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 21 to 60 with a body mass index between 25 and 35 who meet specific metabolic syndrome criteria.

Not a fit: Patients with any type of diabetes or a history of diabetes medication use will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for adults with metabolic syndrome, enhancing their vascular health and insulin sensitivity.

How similar studies have performed: Other studies have shown promising results with similar approaches, particularly in enhancing insulin action and vascular function in metabolic syndrome.

Eligibility criteria

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 this trial is running

Charlottesville, Virginia

• 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

Conditions Metabolic Syndrome