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Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction

NCT ID: NCT00300911

Last Updated: 2006-03-10

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Brief Summary

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The present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function compared with metformin

Detailed Description

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Large scale clinical trials have reported fluid retention and increase in plasma volume (6% to 7%) with glitazone therapy, with an increased incidence of peripheral edema occuring in 2% to 5% patients. Some evidence suggests that this effect may be related to increased endothelial cell permeability induced by glitazones therapy. Others report that glitazones may interfere with renal hemodynamics. In controlled clinical trials, the frequency of new onset congestive heart failure was very low in glitazones treated patients. The incidence of congestive heart failure is higher in patients receiving combination therapy with insulin and glitazones. Only few studies compared rosiglitazone and metformin on cardiac safety. Recently a study reported a reversible increase in endothelial cell permeability to albumin in cultured pulmonary arterial cells treated with rosiglitazone. To our knowledge, there is not any clinical study published for showing the reversibility of the cardiac adverse effects if the rosiglitazone treatment is continued.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rosiglitazone(drug), cardiac adverse effects

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Any known coronary artery disease, congestive hearth failure, renal disease or liver disease
* Any treatment for heart failure or diuretics for any reasons.
Minimum Eligible Age

45 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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Yasemin T Kemal, MD

Role: STUDY_DIRECTOR

Medical Doctor, Internal Medicine

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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Niemeyer NV, Janney LM. Thiazolidinedione-induced edema. Pharmacotherapy. 2002 Jul;22(7):924-9. doi: 10.1592/phco.22.11.924.33626.

Reference Type BACKGROUND
PMID: 12126225 (View on PubMed)

Wooltorton E. Rosiglitazone (Avandia) and pioglitazone (Actos) and heart failure. CMAJ. 2002 Jan 22;166(2):219. No abstract available.

Reference Type BACKGROUND
PMID: 11826947 (View on PubMed)

Idris 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.

Reference Type BACKGROUND
PMID: 12627329 (View on PubMed)

Maeda 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.

Reference Type BACKGROUND
PMID: 9588412 (View on PubMed)

Lubien 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.

Reference Type BACKGROUND
PMID: 11827925 (View on PubMed)

Ogawa 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.

Reference Type BACKGROUND
PMID: 12915698 (View on PubMed)

Other Identifiers

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KA04/164

Identifier Type: -

Identifier Source: org_study_id