NCT00290394

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
Last Updated

February 13, 2006

Status Verified

March 1, 2004

First QC Date

February 9, 2006

Last Update Submit

February 9, 2006

Conditions

Keywords

Blood Pressure,rosiglitazone,Diabetes Mellitus, Type 2,

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Eligibility Criteria

Age49 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Ankara Hospital

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 11872377BACKGROUND
  • 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.

    PMID: 9588454BACKGROUND
  • 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.

    PMID: 9752901BACKGROUND
  • 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.

    PMID: 8934361BACKGROUND
  • 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.

    PMID: 9324109BACKGROUND
  • 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.

    PMID: 7935656BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Neslihan B Tutuncu, MD

    Medical Doctor, Endocrynology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 13, 2006

Study Start

March 1, 2004

Study Completion

August 1, 2004

Last Updated

February 13, 2006

Record last verified: 2004-03

Locations