Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease

NCT00693537 | Completed Phase 4

• 1 other identifier: UISM-2-2008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Coronary Artery Disease

Study Arms (2)

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)

Behavioral: Exercise training

B

NO INTERVENTION

Control

Interventions

Exercise training BEHAVIORAL

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)

A

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paracelsus Medical University: lead

Study Sites (1)

University Institute of Sports Medicine, Prevention and Rehabilitation

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Institute

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 9, 2008
• Last Updated: August 30, 2019

Record last verified: 2008-06

Locations

AU (1)