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

University of Virginia

Status: Unknown

Conditions: Metabolic Syndrome

Treatments: Behavioral: Exercise Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00350064

UVAHIC11145

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)