Ambulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients

This study has been completed.

Sponsor:

Information provided by:

Baskent University

ClinicalTrials.gov Identifier:

NCT00290394

First received: February 9, 2006

Last updated: NA

Last verified: March 2004

History: No changes posted

Tracking Information

First Received Date ^ICMJE

February 9, 2006

Last Updated Date

February 9, 2006

Start Date ^ICMJE

March 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Ambulatory blood pressure monitors used to determine the subjects blood pressure before and after the treatment. At the end of three months period wit rosiglitazone treatment diastolic blood pressure decreased.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ambulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients

Official Title ^ICMJE

Study of PPAR Gamma Agonist-Rosiglitazone in Normotensive Type 2 Diabetics With Ambulatory Blood Pressure Monitoring

Brief Summary

The purpose of this study was to determine the effects of rosiglitazone in normotensive type 2 diabetic patients with regard to its blood-pressure–reducing effects.

Detailed Description

The first study to evaluate the effects of troglitazone on blood pressure in humans was published recently, which demonstrated a 5/4 mm Hg reduction in ambulatory blood pressure in 18 nondiabetic obese subjects after 12 weeks’ treatment. Another study in 18 hypertensive subjects with diabetes mellitus showed an 18/12 mm Hg decline in office blood pressure after 8 weeks of treatment.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: rosiglitazone(drug), blood pressure lowering effect

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Blood pressure of patients were in normotensive limits according to the JNC VII
Diabetes mellitus treated with oral antidiabetics or diet

Exclusion Criteria:

Any known hypertension, coronary artery disease, congestive hearth failure, renal disease or liver disease
Anti-hypertensive treatment

Gender

Both

Ages

49 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT Number ^ICMJE

NCT00290394

Other Study ID Numbers ^ICMJE

KA03/181

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Baskent University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Neslihan B Tutuncu, MD

Medical Doctor, Endocrynology

Information Provided By

Baskent University

Verification Date

March 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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