Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome

Study Overview
=================
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.

Official Title
-----------------
Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: Exercise Training


Participation Criteria
=================
Eligibility Criteria
-----------------
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: visit the outpatient GCRC or clinic once monthly for 16 weeks of intervention, participate in supervised exercise training (if assigned) and 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Exercise Training|16 weeks of aerobic exercise training at two different intensities|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Abdominal Visceral Fat |  | before and after 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2peak |  | before and after 16 weeks | 
| % 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 | 
| CRP |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Syndrome, Obesity, Exercise, Diabetes, Physical Activity