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Clinical Trials/NCT00172536
NCT00172536
Completed
Not Applicable

Effects of Exercise Training on Left Ventricular Function in Type 2 Diabetic Patients Post Coronary Artery Bypass Graft

National Taiwan University Hospital1 site in 1 country65 target enrollmentOctober 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Non-Insulin-Dependent
Sponsor
National Taiwan University Hospital
Enrollment
65
Locations
1
Primary Endpoint
Exercise capacity
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

The purpose of this study is to investigate the changes of cardiorespiratory fitness and left ventricular function in type 2 diabetes after uncomplicated coronary artery bypass graft (CABG) surgery.

We hypothesize that exercise capacity, left ventricular diastolic function, and biochemical data improves after 12-wk exercise training in patients with type 2 diabetes underwent CABG.

Detailed Description

Patients with type 2 diabetes mellitus have higher incidence of coronary artery disease or left ventricular dysfunction, particularly diastolic dysfunction. Coronary artery bypass surgery is known to decrease the mortality rate in diabetes. Further exercise training can improve their cardiorespiratory fitness and the control of risk factors in these patients. However, the extent of improvement and the mechanism, especially the changes in left ventricular function, in diabetes after exercise training have not been fully explored. Subjects will be assigned to the intervention or control group by randomization. Subjects in the intervention group will receive 60% VO2 max moderate aerobic exercise training, twice per week under supervision and three times per week at home, for 12 weeks. All subjects receive left ventricular function test by echocardiography and impedance cardiography, graded maximal exercise test, and biochemical analyses of sugar and lipid before and after 12 weeks. Their dietary intake and physical activity will be inquired every 4 weeks by questionnaires.

Registry
clinicaltrials.gov
Start Date
October 2004
End Date
February 2006
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • well-controlled diabetes
  • no history of myocardial infarction
  • stable post CABG 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

Outcomes

Primary Outcomes

Exercise capacity

Time Frame: Three months after the start of the intervention

Exercise capacity was assessed by peak oxygen uptake (VO2peak)via exercise testing. VO2peak was measured by a metabolic measurement system (Vmax229 Metabolic Measurement System, Sensor Medics, Anaheim, CA).

Diastolic heart function

Time Frame: Three months after the start of the intervention

Echocardiographic examination including color B mode TDI with a commercially available 2.5- to 3.75-MHz phased array transducer (Philips, SONOS 5500, Andover, MA)was used to evaluate diastolic function.

Secondary Outcomes

  • Endothelial function(Three months after the start of the intervention)
  • Hemodynamics(Three times after the start of the intervention)
  • Blood test(Three months after the start of the intervention)

Study Sites (1)

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