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

NCT ID: NCT00290394

Last Updated: 2006-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-08-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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rosiglitazone(drug), blood pressure lowering effect

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

49 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Principal Investigators

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Neslihan B Tutuncu, MD

Role: STUDY_DIRECTOR

Medical Doctor, Endocrynology

Locations

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Baskent University Ankara Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 11872377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9588454 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9752901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8934361 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9324109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7935656 (View on PubMed)

Other Identifiers

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KA03/181

Identifier Type: -

Identifier Source: org_study_id