Trial Outcomes & Findings for Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy) (NCT NCT00543985)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-03-01

Participant Flow

Patients were recruited as part of the parent study on Weight Regain (PI Tom Thomas) funded by NIH. These patients were recruited from clinics, volunteers from advertisements. Patients needed to have 2 of 5 criteria for the Metabolic Syndrome (MetS) plus have obesity.

All patients in this study had successfully been screened as part of the parent study. All patients were to exercise (aerobic) and have a 10% weight loss. Echocardiography was performed prior to and immediately following a maximal stress test at the end of 12 weeks of exercise.

Participant milestones

Participant milestones
Measure	Stress Echocardiography Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
Overall Study STARTED	36
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Stress Echocardiography Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stress Echocardiography n=32 Participants Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' and VO2 max.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37 years STANDARD_DEVIATION 2 • n=5 Participants
Gender Female	15 Participants n=5 Participants
Gender Male	17 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

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.

Outcome measures

Outcome measures
Measure	Stress Echocardiography n=32 Participants Echocardiogram E/E' measured before and after exercise
Mean Resting E/E'	7.01 ml/min/kg Standard Error 0.37

PRIMARY outcome

Timeframe: 12 weeks

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

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.

Outcome measures

Outcome measures
Measure	Stress Echocardiography n=32 Participants Echocardiogram E/E' measured before and after exercise
Post-exercise E/E'	7.41 ml/min/kg Standard Error 0.41

SECONDARY outcome

Timeframe: 12 weeks

Population: This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: This data, if analyzed, is unavailable as the PI/study staff left the institution before completing the analysis and without making results available.

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.

Outcome measures

Outcome data not reported

Adverse Events

Stress Echocardiography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kevin C. Dellsperger, MD, PhD, Professor, Internal Medicine

University of Missouri

Phone: 573-884-2013

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place