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Exercise and the Metabolic Syndrome With Weight Regain (Echocardiography Substudy to Evaluate Effect on Diastolic Function)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00543985
First received: October 11, 2007
Last updated: June 11, 2008
Last verified: June 2008
History of Changes
  Purpose

We plan to test the hypothesis that patients with metabolic syndrome will have impaired left ventricular diastolic parameters. In addition, those who have weight loss and exercise will improve these parameters. Finally, with continued exercise and weight regain, the parameters measured that we believe will be improved will be maintained.


Condition Intervention
Metabolic Syndrome
Obesity
 Behavioral: diet and exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Improvement in diastolic parameters as measured by echocardiography with weight loss and exercise training. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2007
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
10% weight loss and exercise training for 3 months followed by 5% weight regain with continued exercise
 Behavioral: diet and exercise
Exercise training and weight loss with regain with or without continued weight loss
No Intervention: 2
Following baseline training, weight regain of 5% without continued exercise
 Behavioral: diet and exercise
Exercise training and weight loss with regain with or without continued weight loss

Detailed Description:

Patients must have 2 of the 5 criteria for metabolic syndrome and be able to exercise in a monitored setting for 45 min 5 times a week.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2 of 5 criteria for metabolic syndrome
  • Ability to exercise for 45 min 5 days a week

Exclusion Criteria:

  • No diabetes
  • Established coronary disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543985

Contacts
Contact: Tom R Thomas, PhD 573-882-0062 thomastr@missouri.edu
Contact: Kevin C Dellsperger, MD, PhD 573-884-2013 dellspergerk@health.missouri.edu

Locations
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Tom R Thomas, PhD     573-882-0062        
Sub-Investigator: Kevin C Dellsperger, MD, PhD            
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Tom R Thomas, PhD University of Missouri-Columbia
Study Director: Kevin C Dellsperger, MD, PhD University of Missouri-Columbia
Study Director: Anand Chockalingam, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Kevin Dellsperger, MD, University of Missouri
ClinicalTrials.gov Identifier: NCT00543985     History of Changes
Other Study ID Numbers: R01DK067036 (Echo substudy)
Study First Received: October 11, 2007
Last Updated: June 11, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
metabolic syndrome
obesity
exercise

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013