Effects of Exercise Therapy on Ventricular and Endothelia... | NCT01990638

Studies
Effects of Exercise Therapy on Ventricular and Endothelial Function in Patients After Coronary Artery Bypass Surgery

NCT01990638

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Nov 21, 2013Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2

Interventions

exercise capacity test

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Apr 2005Actual

Completion Date

May 2005Actual

First Submitted Date

Nov 15, 2013

First Submission Date that Met QC Criteria

Nov 15, 2013

First Posted Date

Nov 21, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2013

Last Update Posted Date

Nov 21, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study was (1) to compare the peak exercise capacity and left ventricular diastolic function between patients with and without diabetes and (2) to investigate the interrelation among peak oxygen consumption, left ventricular diastolic function, blood sugar, and lipid profile.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

51Actual

Label	Type	Description	Intervention Names
DM group			Other: exercise capacity test
non-DM group			Other: exercise capacity test

Name	Type	Description	Arm Group Labels	Other Names
exercise capacity test	Other		DM group non-DM group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
left ventricular diastolic function	echocardiographic parameters	1 week

Secondary Outcomes

Measure	Description	Time Frame
flow-mediated dilation	flow-mediated dilation on right brachial artery	1 week
exercise capacity	oxygen consumption	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

well-controlled diabetes
no history of myocardial infarction
stable post coronary artery bypass surgery for at least 3 months

Exclusion Criteria:

heart failure,
valvular disease,
abnormal kidney or liver function,
cerebrovascular disease,
primary pulmonary disease,
other systemic or acute illness that may impede the testing or training

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients after coronary artery bypass surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ying-Tai Wu, PhD	National Taiwan University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided