Physical Exercise Versus Rosiglitazone in CAD and Prediab... | NCT00675740

Studies
Physical Exercise Versus Rosiglitazone in CAD and Prediabetes

NCT00675740

Sponsor

University of Leipzig

Status

Completed

Last Update Posted

Feb 2, 2010Estimated

Enrollment

45Actual

Phase

Phase 4

Conditions

Impaired Glucose Tolerance

Interventions

rosiglitazone
physical exercise
control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

May 7, 2008

First Submission Date that Met QC Criteria

May 7, 2008

First Posted Date

May 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2010

Last Update Posted Date

Feb 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: rosiglitazone
2	Active Comparator	physical exercise	Behavioral: physical exercise
3	No Intervention	control	Other: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rosiglitazone	Drug	tablets 4 mg daily	1	Avandia (GlaxoSmithKline)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
between-group difference in flow-mediated dilation of the brachial artery		6 months

Secondary Outcomes

Measure	Description	Time Frame
relative effects of treatment on parameters of - glucose metabolism - inflammatory plasma markers - markers of endothelial function - cellular markers in muscle and fat biopsies		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018149	Glucose Intolerance

Ancestor Terms

ID	Term
D006943	Hyperglycemia
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077154	Rosiglitazone
C023768	halofantrine
D015444	Exercise

Ancestor Terms

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided