Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease - Full Text View

Sponsored by:	Paracelsus Medical University
Information provided by:	Paracelsus Medical University
ClinicalTrials.gov Identifier:	NCT00693537

Purpose

Patients with type 2 diabetes mellitus suffer from accelerated coronary artery disease. We will assess the effects of exercise training on coronary endothelial function, vascular structure, and inflammation both in serum and skeletal muscle biopsies, as well as expression of diabetes candidate genes.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus Coronary Artery Disease	Procedure: Coronary angiography Behavioral: Exercise training	Phase IV

MedlinePlus related topics: Coronary Artery Disease Diabetes Exercise and Physical Fitness

Drug Information available for: Acetylcholine Acetylcholine chloride BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized
Official Title:	Long- But Not Short-Term Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease

Further study details as provided by Paracelsus Medical University:

Arms	Assigned Interventions
A: Experimental 4 weeks in-hospital exercise training (6x15 min bicycle/day, 5 days/week) followed by a 5 months ambulatory exercise program (30 min ergometer/day, 5 days/week, plus 1h group exercise/week)	Procedure: Coronary angiography At baseline, 4 weeks, and 6 months changes in diameter of coronary arteries in response to intracoronary infusion of acetylcholine were analyzed by quantitative coronary angiography, mean peak flow velocity by Doppler velocimetry, and intramural plaques by intravascular ultrasound. Behavioral: Exercise training 4 weeks in-hospital exercise training (6x15 min bicycle/day, 5 days/week) followed by a 5 months ambulatory exercise program (30 min ergometer/day, 5 days/week, plus 1h group exercise/week)
B: No Intervention Control	Procedure: Coronary angiography At baseline, 4 weeks, and 6 months changes in diameter of coronary arteries in response to intracoronary infusion of acetylcholine were analyzed by quantitative coronary angiography, mean peak flow velocity by Doppler velocimetry, and intramural plaques by intravascular ultrasound.

Arms

Assigned Interventions

A: Experimental

4 weeks in-hospital exercise training (6x15 min bicycle/day, 5 days/week) followed by a 5 months ambulatory exercise program (30 min ergometer/day, 5 days/week, plus 1h group exercise/week)

Procedure: Coronary angiography

At baseline, 4 weeks, and 6 months changes in diameter of coronary arteries in response to intracoronary infusion of acetylcholine were analyzed by quantitative coronary angiography, mean peak flow velocity by Doppler velocimetry, and intramural plaques by intravascular ultrasound.

Behavioral: Exercise training

4 weeks in-hospital exercise training (6x15 min bicycle/day, 5 days/week) followed by a 5 months ambulatory exercise program (30 min ergometer/day, 5 days/week, plus 1h group exercise/week)

B: No Intervention

Control

Procedure: Coronary angiography

At baseline, 4 weeks, and 6 months changes in diameter of coronary arteries in response to intracoronary infusion of acetylcholine were analyzed by quantitative coronary angiography, mean peak flow velocity by Doppler velocimetry, and intramural plaques by intravascular ultrasound.

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

written informed consent
preserved left ventricular function (left ventricular ejection fraction ≥ 50%)
a physical work capacity ≥ 50 W
at least one significant coronary stenosis > 50%, whereas either the left anterior descending (LAD) or circumflex artery (RCX) has to be free from disease or stenoses ≤ 25% for the assessment of intracoronary flow measurements

Exclusion Criteria:

diseases further affecting endothelial function
untreated hypertension (systolic blood pressure > 160 mm Hg or a diastolic blood pressure of > 90 mm Hg)
cigarette smoking during the previous six months
LDL-cholesterol > 4.3 mmol/l
ventricular tachyarrhythmias
chronic obstructive pulmonary disease
severe renal or hepatic dysfunction
valvular heart disease
myocardial infarction within the previous 4 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693537

Locations

Austria
University Institute of Sports Medicine, Prevention and Rehabilitation
Salzburg, Austria, 5020

Sponsors and Collaborators

Paracelsus Medical University

More Information

Study ID Numbers:	UISM-2-2008
Study First Received:	June 4, 2008
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00693537
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Ischemia

Arteriosclerosis
Coronary Disease
Diabetes Mellitus, Type 2
Acetylcholine
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009