NCT01990638

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2004

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

5 months

First QC Date

November 15, 2013

Last Update Submit

November 15, 2013

Conditions

Diabetes Mellitus, Type 2

Keywords

coronary artery bypass graftDiabetes mellitus, type 2

Outcome Measures

Primary Outcomes (1)

  • left ventricular diastolic function

    echocardiographic parameters

    1 week

Secondary Outcomes (2)

  • flow-mediated dilation

    1 week

  • exercise capacity

    1 week

Study Arms (2)

DM group

Other: exercise capacity test

non-DM group

Other: exercise capacity test

Interventions

exercise capacity testOTHER
DM groupnon-DM group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients after coronary artery bypass surgery

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

fasting glucose

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ying-Tai Wu, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 21, 2013

Study Start

November 1, 2004

Primary Completion

April 1, 2005

Study Completion

May 1, 2005

Last Updated

November 21, 2013

Record last verified: 2013-11

Locations

TW(1)