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Metabolic SyndromeNCT00350064

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

A study testing Exercise Training in people with Metabolic Syndrome, run by University of Virginia at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome
What is being tested?
Exercise Training
How many people
165 participants
Where
1 siteUnited States
Study dates
Apr 2004to Dec 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Type 1 diabetes,
  • drug or alcohol abuse,
  • psychosis,
  • severe or untreated depression,
  • dementia, polycythemia (hematocrit > 55%),
  • clinically symptomatic coronary artery,
Show all 17Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia General Clinical Research Center

    Charlottesville, Virginia, 22904

Other trials in United States

About this study

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.

Being tested
Exercise Training
Keywords
Metabolic Syndrome, Obesity, Exercise, Diabetes, Physical Activity
Medical subject headings
Metabolic Syndrome, Obesity, Motor Activity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise TrainingBehavioural

    16 weeks of aerobic exercise training at two different intensities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Abdominal Visceral Fat

    Measured: before and after 16 weeks

Secondary outcomes (14)

  1. VO2peak

    Measured: before and after 16 weeks

  2. % Body Fat

    Measured: before and after 16 weeks

  3. Insulin

    Measured: before and after 16 weeks

  4. FFA

    Measured: before and after 16 weeks

  5. Glucose

    Measured: before and after 16 weeks

  6. Hba1c

    Measured: before and after 16 weeks

  7. Cholesterol

    Measured: before and after 16 weeks

  8. CRP

    Measured: before and after 16 weeks

  9. IL6

    Measured: before and after 16 weeks

  10. TNF

    Measured: before and after 16 weeks

  11. Homocysteine

    Measured: before and after 16 weeks

  12. Adiponectin

    Measured: before and after 16 weeks

  13. Adhesion Molecules

    Measured: before and after 16 weeks

  14. Endothelial Function

    Measured: before and after 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2006 (estimated)
  2. Study startApr 2004
  3. Primary completionJun 2006 (estimated)
  4. Study completionDec 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00350064
Sponsor's protocol ID
UVAHIC11145
Status last verified
Aug 2008
First submitted
6 Jul 2006
Last updated
8 Aug 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Training in people with Metabolic Syndrome, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Abdominal Visceral Fat (time frame: before and after 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00350064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2008.

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