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

Coronary Arteriosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00172536
• Other study ID #: 9361701147
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: April 21, 2011
• Start date: October 2004
• Est. completion date: February 2006

Study information

• Verified date: March 2011
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2
• Myocardial Ischemia
• Post Coronary Artery Bypass Grafting

Intervention

Behavioral:
• Exercise training
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.

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity	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).	Three months after the start of the intervention	No
Primary	Diastolic heart function	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.	Three months after the start of the intervention	No
Secondary	Endothelial function	Examined by flow-mediated vasodilation	Three months after the start of the intervention	No
Secondary	Hemodynamics	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	Three times after the start of the intervention	No
Secondary	Blood test	Including fasting glucose, HbA1c, total cholesterol (TC), high-density liporpotein (HDL-c) and triglyceride (TG).	Three months after the start of the intervention	No