NCT00350064

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 8, 2008

Status Verified

August 1, 2008

Enrollment Period

2.2 years

First QC Date

July 6, 2006

Last Update Submit

August 7, 2008

Conditions

Metabolic Syndrome

Keywords

Metabolic SyndromeObesityExerciseDiabetesPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Change in Abdominal Visceral Fat

    before and after 16 weeks

Secondary Outcomes (14)

  • 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

  • +9 more secondary outcomes

Interventions

Exercise TrainingBEHAVIORAL

16 weeks of aerobic exercise training at two different intensities

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,
  • st or 2nd generation anti-psychotics insulin, or Viagra,
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia General Clinical Research Center

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeObesityMotor ActivityDiabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Arthur Weltman, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

  • Brian A Irving, PhD

    University of Virginia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 10, 2006

Study Start

April 1, 2004

Primary Completion

June 1, 2006

Study Completion

December 1, 2008

Last Updated

August 8, 2008

Record last verified: 2008-08

Locations

US(1)