Skip to main content
Clinical Trials/NCT03894527
NCT03894527
Unknown
Not Applicable

Impact of Acute Exercise on Vascular Insulin Sensitivity in Metabolic Syndrome

University of Virginia1 site in 1 country16 target enrollmentFebruary 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metabolic Syndrome
Sponsor
University of Virginia
Enrollment
16
Locations
1
Primary Endpoint
Effect of single bout of exercise on FMD
Last Updated
7 years ago

Overview

Brief Summary

Obesity is an independent risk factor for type 2 diabetes and cardiovascular disease. The increased prevalence of obesity worldwide is a major concern among the scientific and medical communities. Insulin resistance is a common factor associated with obesity, metabolic syndrome, hypertension, and type 2 diabetes. Individuals affected by these conditions often experience endothelial dysfunction as well. Insulin resistance provides a key link between metabolic syndrome risk factors and vascular disease. Development of strategies aimed at preventing vascular dysfunction and future disease caused by metabolic disturbances is needed. Although the relationship between obesity and various diseases is well known, the acute effects of insulin on vascular function in obese individuals have yet to be fully determined. Additionally, the effects of acute exercise on insulin-stimulated endothelial function are unknown. Exercise may be an effective and potent treatment that protects against endothelial dysfunction, insulin resistance, and future cardiometabolic disease commonly present with obesity. However, less attention has been placed on vascular insulin sensitivity. The purpose of this study is to test the hypothesis that a single bout of exercise increases insulin-stimulated blood flow at the macro- and micro-vasculature level in obese individuals with metabolic syndrome to similar levels as healthy obese control. Our laboratory has available non-invasive methods to quantify vascular function and the gold-standard technique for assessing insulin sensitivity (euglycemic-hyperinsulinemic clamp). The investigators will assess vascular function (flow-mediated dilation, post-ischemic flow velocity and contrast-enhanced ultrasound) as well as arterial stiffness (augmentation index and pulse wave velocity) before and at the end of the clamp protocol performed the morning following a bout of exercise and a control (no-exercise) condition in 1) metabolic syndrome and 2) obese adults. If our hypothesis is sustained, it will suggest that a key role of the vasculature exists in regulating insulin following exercise and will provide insight into the link between the vasculature, obesity, metabolic syndrome and cardiovascular disease and may confer decreased risk for cardiometabolic disease.

Registry
clinicaltrials.gov
Start Date
February 18, 2019
End Date
January 31, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven K. Malin, PhD

Assitant Professor

University of Virginia

Eligibility Criteria

Inclusion Criteria

  • Males and females, ages 40-70 years
  • Never diagnosed with type 2 diabetes and/or cardiovascular disease
  • Not currently engaged in \> 60 min/wk of exercise
  • Inclusion criteria specific to health obese vs. metabolic syndrome potential participants:
  • Healthy Obese: (BMI ≥ 30 kg/m2 but ≤ 45 kg/m2) and no other metabolic syndrome risk factors, excluding waist circumference.
  • Metabolic Syndrome: (BMI ≥ 30 kg/m2 but ≤ 45 kg/m2) and must meet at least 3 out of 5 National Cholesterol Education Adult Treatment Panel III Metabolic Syndrome Criteria:
  • Increased waist circumference (≥102 cm in men; ≥88 cm in women) Elevated triglycerides (≥150 mg/dl) or currently taking medication (Rx) Reduced HDL-cholesterol (\<40mg/dl in men, \<50 mg/dl in women) or currently taking medication (Rx) High blood pressure (≥130 mmHg systolic or ≥85mmHg diastolic) or currently taking medication (Rx) Elevated fasting glucose (≥100 mg/dl)
  • Subject may participate if on the following drugs:
  • Diuretics, ace-inhibitors and ARBs for treatment of hypertension

Exclusion Criteria

  • Morbidly obese patients (BMI \>45 kg/m2) and overweight/lean patients (BMI \<30 kg/m2).
  • Subjects who have not been weight stable (\>2kg weight change in past 3 months).
  • Currently participating in a regular exercise training program ( \>30 min. of physical activity per day, \>2 days/week)
  • Medication or food supplement that is known to affect insulin sensitivity or endothelial function (TZDs, sulfonylureas, biguanides, alpha-glucosidase inhibitors, phosphodiesterase inhibitors, beta-blockers, alpha-blockers, fibrates, glucocorticoids, fish oil, allopurinol)
  • Subjects with abnormal estimated glomerular filtration rate (eGFR).
  • Hypertriglyceridemic (\>400 mg/dl) subjects.
  • Hypertensive (\>160/100 mmHg)
  • Subjects taking vasoactive medications also known to affect heart rate and rhythm (i.e. Ca++ channel blockers, nitrates, alpha- or beta-blockers).
  • Subjects with a history of significant metabolic, cardiac, congestive heart failure, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures, or impact subject safety.
  • Smoking presently or in the past 1 year.

Outcomes

Primary Outcomes

Effect of single bout of exercise on FMD

Time Frame: Baseline clamp study

Flow Mediated Dilation (FMD) as a percentage

Effect of single bout of exercise on CEU

Time Frame: Baseline Clamp Study

Contrast Enhanced Ultrasound (CEU) as a percentage

Comparison of insulin stimulated FMD response

Time Frame: Through study completion, up to about 4 weeks

Flow mediated dilation as a percentage of fasting values

Comparison of insulin stimulated CEU response

Time Frame: Through study completion, up to about 4 weeks

Contrast Enhanced Ultrasound (CEU) as a percentage of fasting values

Secondary Outcomes

  • Central Arterial Stiffness(Through study completion, up to about 4 weeks)
  • Systemic Arterial stiffness(Through study completion, up to about 4 weeks)
  • Metabolic Flexibility(Through study completion, up to about 4 weeks)
  • Fasting glucose(Through study completion, up to about 4 weeks)
  • Fasting insulin(Through study completion, up to about 4 weeks)
  • Free Fatty Acids(Through study completion, up to about 4 weeks)
  • Adiponectin(Through study completion, up to about 4 weeks)

Study Sites (1)

Loading locations...

Similar Trials