Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction
A Study of PPAR-Gamma Agonist-Rosiglitazone for Determining Cardiac Adverse Effects in Type 2 Diabetic Patients
1 other identifier
interventional
45
1 country
1
Brief Summary
The present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function compared with metformin
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 diabetes-mellitus-type-2
1 active site
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
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 9, 2006
CompletedFirst Posted
Study publicly available on registry
March 10, 2006
CompletedMarch 10, 2006
November 1, 2005
March 9, 2006
March 9, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma Brain Natriuretic Peptide levels, echocardiographic measurements were made before the treatment and repeated after three months and six months of the treatment
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus treated with oral hypoglycemic agents or diet only
- Without any symptom or finding of heart failure
- Normal liver enzymes and renal functions
You may not qualify if:
- Any known coronary artery disease, congestive hearth failure, renal disease or liver disease
- Any treatment for heart failure or diuretics for any reasons.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baskent University Ankara Hospital
Ankara, 06490, Turkey (Türkiye)
Related Publications (6)
Niemeyer NV, Janney LM. Thiazolidinedione-induced edema. Pharmacotherapy. 2002 Jul;22(7):924-9. doi: 10.1592/phco.22.11.924.33626.
PMID: 12126225BACKGROUNDWooltorton E. Rosiglitazone (Avandia) and pioglitazone (Actos) and heart failure. CMAJ. 2002 Jan 22;166(2):219. No abstract available.
PMID: 11826947BACKGROUNDIdris I, Gray S, Donnelly R. Rosiglitazone and pulmonary oedema: an acute dose-dependent effect on human endothelial cell permeability. Diabetologia. 2003 Feb;46(2):288-90. doi: 10.1007/s00125-002-1008-1. Epub 2003 Feb 12.
PMID: 12627329BACKGROUNDMaeda K, Tsutamoto T, Wada A, Hisanaga T, Kinoshita M. Plasma brain natriuretic peptide as a biochemical marker of high left ventricular end-diastolic pressure in patients with symptomatic left ventricular dysfunction. Am Heart J. 1998 May;135(5 Pt 1):825-32. doi: 10.1016/s0002-8703(98)70041-9.
PMID: 9588412BACKGROUNDLubien E, DeMaria A, Krishnaswamy P, Clopton P, Koon J, Kazanegra R, Gardetto N, Wanner E, Maisel AS. Utility of B-natriuretic peptide in detecting diastolic dysfunction: comparison with Doppler velocity recordings. Circulation. 2002 Feb 5;105(5):595-601. doi: 10.1161/hc0502.103010.
PMID: 11827925BACKGROUNDOgawa S, Takeuchi K, Ito S. Plasma BNP levels in the treatment of type 2 diabetes with pioglitazone. J Clin Endocrinol Metab. 2003 Aug;88(8):3993-6. doi: 10.1210/jc.2002-021765.
PMID: 12915698BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yasemin T Kemal, MD
Medical Doctor, Internal Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 9, 2006
First Posted
March 10, 2006
Study Start
December 1, 2005
Last Updated
March 10, 2006
Record last verified: 2005-11