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

Obesity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00543985
• Other study ID #: R01DK067036 (Echo substudy)
• Status: Recruiting
• Phase: N/A
• First received: October 11, 2007
• Last updated: June 11, 2008
• Start date: October 2007
• Est. completion date: October 2008

Study information

• Verified date: June 2008
• Source: University of Missouri-Columbia
• Contact: Tom R Thomas, PhD
• Phone: 573-882-0062
• Email: thomastr[@]missouri.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Behavioral:
• diet and exercise
Exercise training and weight loss with regain with or without continued weight loss

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in diastolic parameters as measured by echocardiography with weight loss and exercise training.		3 months	No