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Control for Metabolic Syndrome

N/A
Waitlist Available
Led By Steve Malin, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to about 4 weeks
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Metabolic Syndrome
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline clamp study
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline clamp study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comparison of insulin stimulated CEU response
Insulin
Effect of single bout of exercise on CEU
+1 more
Secondary study objectives
Adiponectin
Central Arterial Stiffness
Fasting glucose
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: ControlActive Control2 Interventions
Subjects with simple obesity will complete 2 different testing conditions in a counterbalanced order with at least one week between conditions. 10-12 hrs post test condition the subject will report for a Euglycemic-Hyperinsulinemic clamp study, where Flow Mediated Dilation (FMD) and Contrast Enhanced Ultrasound (CEU) will be performed.
Group II: Metabolic SyndromeActive Control2 Interventions
Subjects with metabolic syndrome will complete 2 different testing conditions in a counterbalanced order with at least one week between conditions. 10-12 hrs post test condition the subject will report for a Euglycemic-Hyperinsulinemic clamp study, where Flow Mediated Dilation (FMD) and Contrast Enhanced Ultrasound (CEU) will be performed.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
781 Previous Clinical Trials
1,315,654 Total Patients Enrolled
5 Trials studying Metabolic Syndrome
542 Patients Enrolled for Metabolic Syndrome
American College of Sports MedicineOTHER
11 Previous Clinical Trials
333 Total Patients Enrolled
Steve Malin, PhDPrincipal InvestigatorUniversity of Virginia
~2 spots leftby Nov 2025