NCT00543985

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Status
completed

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

October 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2007

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

November 22, 2016

Completed
Last Updated

March 1, 2017

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

October 11, 2007

Results QC Date

January 11, 2010

Last Update Submit

January 17, 2017

Conditions

Keywords

metabolic syndromeobesityexercise

Outcome Measures

Primary Outcomes (2)

  • Mean Resting E/E'

    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'

    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 Outcomes (2)

  • Mean Resting Maximal Oxygen Uptake (VO2 Max)

    12 weeks

  • Change in Maximal Oxygen Uptake (VO2 Max)

    12 weeks

Study Arms (1)

Stress Echocardiography

EXPERIMENTAL

Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.

Procedure: Stress Echocardiography

Interventions

Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol.

Stress Echocardiography

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • No diabetes
  • Established coronary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chockalingam A, Linden MA, Dellsperger KC, Thomas TR. Correlation of Normal Diastolic Cardiac Function With VO in the Metabolic Syndrome. Prev Cardiol. 2009 Summer;12(3):163-8. doi: 10.1111/j.1751-7141.2009.00027.x.

MeSH Terms

Conditions

Metabolic SyndromeObesityMotor Activity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Kevin C. Dellsperger, MD, PhD, Professor, Internal Medicine
Organization
University of Missouri

Study Officials

  • Tom R Thomas, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR
  • Kevin C Dellsperger, MD, PhD

    University of Missouri-Columbia

    STUDY DIRECTOR
  • Anand Chockalingam, MD

    University of Missouri-Columbia

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2007

First Posted

October 15, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 1, 2017

Results First Posted

November 22, 2016

Record last verified: 2016-11