Ambulatory Blood Pressure Reduction After Rosiglitazone Treatment In Normotensive Type 2 Diabetic Patients
Information source: Baskent University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: rosiglitazone(drug), blood pressure lowering effect (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Baskent University Official(s) and/or principal investigator(s):
Neslihan B Tutuncu, MD, Study Director, Affiliation: Medical Doctor, Endocrynology
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.
Clinical Details
Official title: Study of PPAR Gamma Agonist-Rosiglitazone in Normotensive Type 2 Diabetics With Ambulatory Blood Pressure Monitoring
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
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
Minimum age: 49 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Baskent University Ankara Hospital, Ankara 06490, Turkey
Additional Information
Related publications: Takano H, Komuro I. Roles of peroxisome proliferator-activated receptor gamma in cardiovascular disease. J Diabetes Complications. 2002 Jan-Feb;16(1):108-14. Review. 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. 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. 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. 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. 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.
Starting date: March 2004
Ending date: August 2004
Last updated: February 9, 2006
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