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Completed

NCT Number: NCT00300911

Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction

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

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baskent University Ankara Hospital

Ankara, 06490, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosiglitazone(drug), cardiac adverse effects

Drug

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

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

A Study of PPAR-Gamma Agonist-Rosiglitazone for Determining Cardiac Adverse Effects in Type 2 Diabetic Patients

Important dates

Study start
2005
First posted
Mar 10, 2006
Registry last updated
Mar 10, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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