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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00350064
• Other study ID #: UVAHIC11145
• Status: Active, not recruiting
• Phase: N/A
• First received: July 6, 2006
• Last updated: August 7, 2008
• Start date: April 2004
• Est. completion date: December 2008

Study information

• Verified date: August 2008
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: December 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• Exercise Training
16 weeks of aerobic exercise training at two different intensities

Locations

Country	Name	City	State
United States	University of Virginia General Clinical Research Center	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Abdominal Visceral Fat		before and after 16 weeks	No
Secondary	VO2peak		before and after 16 weeks	No
Secondary	% Body Fat		before and after 16 weeks	No
Secondary	Insulin		before and after 16 weeks	No
Secondary	FFA		before and after 16 weeks	No
Secondary	Glucose		before and after 16 weeks	No
Secondary	Hba1c		before and after 16 weeks	No
Secondary	Cholesterol		before and after 16 weeks	No
Secondary	CRP		before and after 16 weeks	No
Secondary	IL6		before and after 16 weeks	No
Secondary	TNF		before and after 16 weeks	No
Secondary	Homocysteine		before and after 16 weeks	No
Secondary	Adiponectin		before and after 16 weeks	No
Secondary	Adhesion Molecules		before and after 16 weeks	No
Secondary	Endothelial Function		before and after 16 weeks	No