Physical Exercise Versus Rosiglitazone in CAD and Prediabetes - Full Text View

Sponsor:	University of Leipzig
Information provided by:	University of Leipzig
ClinicalTrials.gov Identifier:	NCT00675740

Purpose

The aim of this study is to prospectively assess the relative benefits of either treatment with rosiglitazone or physical exercise on endothelial function in patients with impaired fasting glucose or impaired glucose tolerance and coronary artery disease (CAD).

Condition	Intervention	Phase
Impaired Glucose Tolerance	Drug: rosiglitazone Behavioral: physical exercise Other: control	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Physical Exercise Versus Rosiglitazone on Endothelial Function in Coronary Artery Disease Patients With Prediabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Coronary Artery Disease Exercise and Physical Fitness Pre-diabetes

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:

between-group difference in flow-mediated dilation of the brachial artery [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

relative effects of treatment on parameters of - glucose metabolism - inflammatory plasma markers - markers of endothelial function - cellular markers in muscle and fat biopsies [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	45
Study Start Date:	January 2004
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: rosiglitazone tablets 4 mg daily Other Name: Avandia (GlaxoSmithKline)
Active Comparator: 2 physical exercise	Behavioral: physical exercise stationary bike 5-6 times a week
No Intervention: 3 control	Other: control control without intervention

Eligibility

Ages Eligible for Study:	35 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

impaired fasting glucose or impaired glucose tolerance
angiographic evidence of coronary artery disease

Exclusion Criteria:

diabetes mellitus type I or II
preexisting antidiabetic medication
unstable angina
indication for coronary bypass surgery
significant left main disease
myocardial infarction within preceding 3 months
ejection fraction < 40%
significant heart valve disease
severe metabolic disorders
severe disorders in lipoprotein metabolism
thyroid disorders
alcohol or drug abuse
pregnancy
participation in another trial

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Steffen Desch, University of Leipzig
ClinicalTrials.gov Identifier:	NCT00675740 History of Changes
Other Study ID Numbers:	Leipzig 03
Study First Received:	May 7, 2008
Last Updated:	February 1, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Coronary Artery Disease
Glucose Intolerance
Prediabetic State
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012