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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00290394
First Posted: February 13, 2006
Last Update Posted: February 13, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Baskent University
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2 Drug: rosiglitazone(drug), blood pressure lowering effect Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of PPAR Gamma Agonist-Rosiglitazone in Normotensive Type 2 Diabetics With Ambulatory Blood Pressure Monitoring

Resource links provided by NLM:


Further study details as provided by Baskent University:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 25
Study Start Date: March 2004
Estimated Study Completion Date: August 2004
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   49 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290394


Locations
Turkey
Baskent University Ankara Hospital
Ankara, Turkey, 06490
Sponsors and Collaborators
Baskent University
Investigators
Study Director: Neslihan B Tutuncu, MD Medical Doctor, Endocrynology
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00290394     History of Changes
Other Study ID Numbers: KA03/181
First Submitted: February 9, 2006
First Posted: February 13, 2006
Last Update Posted: February 13, 2006
Last Verified: March 2004

Keywords provided by Baskent University:
Blood Pressure,
rosiglitazone,Diabetes Mellitus, Type 2,

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs