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

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 4


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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Diabetes Type 2 Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Paracelsus Medical University:

Arms	Assigned Interventions
Experimental: A 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)
No Intervention: B 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

Experimental: A

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)

No Intervention: B

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Coronary Artery Disease Myocardial Ischemia Coronary Disease Glucose Metabolism Disorders Metabolic Diseases	Endocrine System Diseases Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2016