Clinical trial NCT00350064: Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome
Official title: Impact of Exercise Training Intensity on Abdominal Visceral Fat and Risk Factors Associated With the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Obesity
Exercise
Diabetes
Physical Activity
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2006-07-10
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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:

  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.

Primary outcomes:
measure: Change in Abdominal Visceral Fat
timeFrame: before and after 16 weeks
Secondary outcomes:
measure: VO2peak
timeFrame: before and after 16 weeks
measure: % Body Fat
timeFrame: before and after 16 weeks
measure: Insulin
timeFrame: before and after 16 weeks
measure: FFA
timeFrame: before and after 16 weeks
measure: Glucose
timeFrame: before and after 16 weeks
measure: Hba1c
timeFrame: before and after 16 weeks
measure: Cholesterol
timeFrame: before and after 16 weeks
measure: CRP
timeFrame: before and after 16 weeks
measure: IL6
timeFrame: before and after 16 weeks
measure: TNF
timeFrame: before and after 16 weeks
measure: Homocysteine
timeFrame: before and after 16 weeks
measure: Adiponectin
timeFrame: before and after 16 weeks
measure: Adhesion Molecules
timeFrame: before and after 16 weeks
measure: Endothelial Function
timeFrame: before and after 16 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia General Clinical Research Center
state: Virginia
Study officials:
affiliation: University of Virginia
name: Arthur Weltman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Brian A Irving, PhD
role: STUDY_DIRECTOR
References: