Back to resultsAmbulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
rosiglitazone(drug), blood pressure lowering effect
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Blood Pressure,, rosiglitazone,Diabetes Mellitus, Type 2,
Eligibility 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
Sites / Locations
- Baskent University Ankara Hospital
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00290394
Brief Title
Ambulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients
Official Title
Study of PPAR Gamma Agonist-Rosiglitazone in Normotensive Type 2 Diabetics With Ambulatory Blood Pressure Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
March 2004
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Baskent University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Blood Pressure,, rosiglitazone,Diabetes Mellitus, Type 2,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
rosiglitazone(drug), blood pressure lowering effect
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neslihan B Tutuncu, MD
Organizational Affiliation
Medical Doctor, Endocrynology
Official's Role
Study Director
Facility Information:
Facility Name
Baskent University Ankara Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
11872377
Citation
Takano H, Komuro I. Roles of peroxisome proliferator-activated receptor gamma in cardiovascular disease. J Diabetes Complications. 2002 Jan-Feb;16(1):108-14. doi: 10.1016/s1056-8727(01)00203-3.
Results Reference
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PubMed Identifier
9588454
Citation
Walker AB, Naderali EK, Chattington PD, Buckingham RE, Williams G. Differential vasoactive effects of the insulin sensitizers rosiglitazone (BRL 49653) and troglitazone on human small arteries in vitro. Diabetes. 1998 May;47(5):810-4. doi: 10.2337/diabetes.47.5.810.
Results Reference
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PubMed Identifier
9752901
Citation
Fujishima S, Ohya Y, Nakamura Y, Onaka U, Abe I, Fujishima M. Troglitazone, an insulin sensitizer, increases forearm blood flow in humans. Am J Hypertens. 1998 Sep;11(9):1134-7. doi: 10.1016/s0895-7061(98)00130-7.
Results Reference
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PubMed Identifier
8934361
Citation
Chen S, Noguchi Y, Izumida T, Tatebe J, Katayama S. A comparison of the hypotensive and hypoglycaemic actions of an angiotensin converting enzyme inhibitor, an AT1a antagonist and troglitazone. J Hypertens. 1996 Nov;14(11):1325-30. doi: 10.1097/00004872-199611000-00011.
Results Reference
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PubMed Identifier
9324109
Citation
Saku K, Zhang B, Ohta T, Arakawa K. Troglitazone lowers blood pressure and enhances insulin sensitivity in Watanabe heritable hyperlipidemic rabbits. Am J Hypertens. 1997 Sep;10(9 Pt 1):1027-33. doi: 10.1016/s0895-7061(97)00160-x.
Results Reference
background
PubMed Identifier
7935656
Citation
Nolan JJ, Ludvik B, Beerdsen P, Joyce M, Olefsky J. Improvement in glucose tolerance and insulin resistance in obese subjects treated with troglitazone. N Engl J Med. 1994 Nov 3;331(18):1188-93. doi: 10.1056/NEJM199411033311803.
Results Reference
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Ambulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients
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