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Completed

NCT Number: NCT00172536

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Training

Behavioral

Subjects attended a supervised treadmill training session three times per week in an outpatient facility for three months. Training duration was 30 minutes per session, including a 5-minute warm-up and cool-down phase. Training intensity was initially set at about 60% of HR reserve and close to the anerobic threshold (AT) and the gradually increased as tolerated.

Control

Other

Subjects received general education including proper diet, regular physical activity or medical care if necessary through an interview with a physical therapist.

Primary outcomes

  1. 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).

  2. 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

  1. Endothelial function

    Time frame: Three months after the start of the intervention

    Examined by flow-mediated vasodilation

  2. Hemodynamics

    Time frame: Three times after the start of the intervention

    Heart rate (HR) and stroke volume (SV) were collected at rest, during the exercise test, and during the recovery phase by a noninvasive bioimpedance cardiograph device (PhysioFlow PF-05, Manatec Biomedical, Paris, France). Cardiac output (CO) and arteriovenous oxygen difference ((a-v)O2 difference) were then determined by the following equations: CO=HR*SV and (a-v)O2 difference=VO2/SV*HR

  3. Blood test

    Time frame: Three months after the start of the intervention

    Including fasting glucose, HbA1c, total cholesterol (TC), high-density liporpotein (HDL-c) and triglyceride (TG).

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Apr 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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