Metabolic Syndrome
Conditions
Keywords
Metabolic Syndrome, Obesity, Exercise, Diabetes, Physical Activity
Brief summary
The purpose of this study is to determine if sixteen weeks of high intensity physical training is more effective than sixteen weeks of low intensity physical training in reducing abdominal fat and lowering risk factors associated with the metabolic syndrome. Another aim of this study is to determine if high intensity physical training improves cognitive function.
Interventions
BEHAVIORALExercise Training
16 weeks of aerobic exercise training at two different intensities
Sponsors
National Center for Research Resources (NCRR)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Volunteers must have meet the definition of the metabolic syndrome (based on IDF consensus statement). * Screening biochemical tests of liver, kidney, hematologic, metabolic (below) and thyroid function must be normal. * The volunteer must be willing to: 1. visit the outpatient GCRC or clinic once monthly for 16 weeks of intervention, 2. participate in supervised exercise training (if assigned) and 3. enter the inpatient GCRC for 2-3 days of more intensive studies at baseline and after 16 weeks of intervention. The subject must provide voluntary and fully informed written consent.
Exclusion criteria
* Type 1 diabetes, * drug or alcohol abuse, * psychosis, * severe or untreated depression, * dementia, polycythemia (hematocrit \> 55%), * clinically symptomatic coronary artery, * pulmonary or orthopedic disease (which would disallow exercise training), * history of vascular or peripheral nerve trauma, * lymph node dissection, * anemia, uncontrolled hypertension (\> 160/105 untreated or \> 145/95 treated), * allergic to octafluoropropane, or nitroglycerine, * weight loss or gain of 2 kg or more within the preceding 10 days, * investigational drug use within five biological half-lives, * treatment with ACE inhibitors or ARBs, thiazolindiones, * 1st or 2nd generation anti-psychotics insulin, or Viagra, * unwillingness to provide written informed voluntary consent, * pregnant, breast feeding or use hormonal birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Abdominal Visceral Fat | before and after 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| % Body Fat | before and after 16 weeks |
| Insulin | before and after 16 weeks |
| FFA | before and after 16 weeks |
| Glucose | before and after 16 weeks |
| Hba1c | before and after 16 weeks |
| Cholesterol | before and after 16 weeks |
| VO2peak | before and after 16 weeks |
| IL6 | before and after 16 weeks |
| TNF | before and after 16 weeks |
| Homocysteine | before and after 16 weeks |
| Adiponectin | before and after 16 weeks |
| Adhesion Molecules | before and after 16 weeks |
| Endothelial Function | before and after 16 weeks |
| CRP | before and after 16 weeks |
Countries
United States
Outcome results
None listed