Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00300911
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : March 10, 2006
Information provided by:
Baskent University

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Rosiglitazone(drug), cardiac adverse effects Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of PPAR-Gamma Agonist-Rosiglitazone for Determining Cardiac Adverse Effects in Type 2 Diabetic Patients
Study Start Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Plasma Brain Natriuretic Peptide levels, echocardiographic measurements were made before the treatment and repeated after three months and six months of the treatment

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00300911

Baskent University Ankara Hospital
Ankara, Turkey, 06490
Sponsors and Collaborators
Baskent University
Study Director: Yasemin T Kemal, MD Medical Doctor, Internal Medicine

Publications: Identifier: NCT00300911     History of Changes
Other Study ID Numbers: KA04/164
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: March 10, 2006
Last Verified: November 2005

Keywords provided by Baskent University:
Natriuretic Peptide, Brain
Heart Failure, Congestive

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs