Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

January 17, 2017 updated by: University of Missouri-Columbia

Exercise in Patients With Metabolic Syndrome and Weight Regain - Echocardiography Substudy

We plan to test the hypothesis that patients with metabolic syndrome will have impaired left ventricular diastolic parameters. These parameters will be measured before and after a stress test at the end of a 3 month period of exercise training and a 10% weight loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stress Echocardiography
Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
Procedure: Stress Echocardiography
Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Resting E/E'
Time Frame: 12 weeks
E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants prior to treadmill stress test.
12 weeks
Post-exercise E/E'
Time Frame: 12 weeks
E/E' is an echocardiographic parameter where E = early mitral inflow velocity and E' = early diastolic mitral annular motion. Measured in all participants immediately following treadmill stress test.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Resting Maximal Oxygen Uptake (VO2 Max)
Time Frame: 12 weeks
Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min). Measured in all participants prior to treadmill stress test.
12 weeks
Change in Maximal Oxygen Uptake (VO2 Max)
Time Frame: 12 weeks
Measure of the maximum volume of oxygen that a body is capable of utilizing in one minute, measured in milliliters per kilogram of body weight per minute (ml/kg/min) Measured in all participants immediately following treadmill stress test.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

October 11, 2007

First Submitted That Met QC Criteria

October 12, 2007

First Posted (Estimate)

October 15, 2007

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DK067036 (Echo substudy)
  • R01DK067036 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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