Overview

This trial is active, not recruiting.

Condition metabolic syndrome
Treatment exercise training
Sponsor University of Virginia
Collaborator National Center for Research Resources (NCRR)
Start date April 2004
End date June 2006
Trial size 165 participants
Trial identifier NCT00350064, UVAHIC11145

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Change in Abdominal Visceral Fat
time frame: before and after 16 weeks

Secondary Outcomes

Measure
VO2peak
time frame: before and after 16 weeks
% Body Fat
time frame: before and after 16 weeks
Insulin
time frame: before and after 16 weeks
FFA
time frame: before and after 16 weeks
Glucose
time frame: before and after 16 weeks
Hba1c
time frame: before and after 16 weeks
Cholesterol
time frame: before and after 16 weeks
CRP
time frame: before and after 16 weeks
IL6
time frame: before and after 16 weeks
TNF
time frame: before and after 16 weeks
Homocysteine
time frame: before and after 16 weeks
Adiponectin
time frame: before and after 16 weeks
Adhesion Molecules
time frame: before and after 16 weeks
Endothelial Function
time frame: before and after 16 weeks

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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.

Additional Information

Official title Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome
Principal investigator Arthur Weltman, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2008.
Information provided to ClinicalTrials.gov by University of Virginia.