Metabolic SyndromeNCT00543985

Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

A study testing Stress Echocardiography in people with Metabolic Syndrome and Obesity, run by University of Missouri-Columbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Metabolic Syndrome, Obesity
What is being tested?: Stress Echocardiography
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: No sites listed yet
Study dates: Oct 2007to Oct 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

No diabetes
Established coronary disease

About this study

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

Read the 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.

Conditions: Metabolic Syndrome, Obesity
Being tested: Stress Echocardiography
Keywords: metabolic syndrome, obesity, exercise
Medical subject headings: Metabolic Syndrome, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00543985
Study group	Role	What they receive
Stress Echocardiography	Experimental	Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol. Receives: Procedure: Stress Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 12 weeks

Secondary outcomes (2)

Mean Resting Maximal Oxygen Uptake (VO2 Max)
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.
Measured: 12 weeks
Change in Maximal Oxygen Uptake (VO2 Max)
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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Oct 2008

First posted15 Oct 2007 (estimated)
Study startOct 2007
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00543985
Sponsor's protocol ID: R01DK067036 (Echo substudy)
Other IDs: R01DK067036
Status last verified: Nov 2016
First submitted: 11 Oct 2007
Last updated: 1 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 19523060

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exercise in Patients With Metabolic Syndrome and Weight Regain - Echocardiography Substudy
ClinicalTrials.gov ID: NCT00543985
Acronym / sponsor ID: R01DK067036 (Echo substudy)
Conditions: Metabolic Syndrome, Obesity
Keywords: metabolic syndrome, obesity, exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: University of Missouri-ColumbiaUniversity, hospital or other
Study start: Oct 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 15 Oct 2007 (estimated)
Results: Posted 22 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Stress Echocardiography	Experimental	Procedure: Stress EchocardiographyEchocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

No diabetes
Established coronary disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stress EchocardiographyEchocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol.	Procedure or surgery	Stress Echocardiography

Primary outcome

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.
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.

2 secondary outcomes

Mean Resting Maximal Oxygen Uptake (VO2 Max)
Time frame: 12 weeks
Change in Maximal Oxygen Uptake (VO2 Max)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 22 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stress Echocardiography	36	32

Primary outcome: Mean Resting E/E'

Time frame: 12 weeks. Mean (Standard Error). Unit: ml/min/kg

Measure	Stress Echocardiography n = 32
Value	7.01 (0.37)

Stress Echocardiography: Pearson correlation coefficient: -0.266, p =0.14, Regression, Linear

Population analysed: The echo results from all subjects were analyzed at rest and following maximal exercise testing.

Primary outcome: Post-exercise E/E'

Time frame: 12 weeks. Mean (Standard Error). Unit: ml/min/kg

Measure	Stress Echocardiography n = 32
Value	7.41 (0.41)

Population analysed: The echo results from all subjects were analyzed at rest and following maximal exercise testing.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stress Echocardiography	0 of 32 (0%)	0 of 32 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19523060Chockalingam 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.

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
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Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tom R Thomas, PhD principal investigator

University of Missouri-Columbia

Kevin C Dellsperger, MD, PhD study director

University of Missouri-Columbia

Anand Chockalingam, MD study director

University of Missouri-Columbia

Questions about this trial

What is this clinical trial studying?

A study testing Stress Echocardiography in people with Metabolic Syndrome and Obesity, run by University of Missouri-Columbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Resting E/E' (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00543985, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.