Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction

This study has been completed.
Sponsor:
Information provided by:
Baskent University
ClinicalTrials.gov Identifier:
NCT00300911
First received: March 9, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of PPAR-Gamma Agonist-Rosiglitazone for Determining Cardiac Adverse Effects in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Baskent University:

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

Estimated Enrollment: 45
Study Start Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300911

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

Publications:
ClinicalTrials.gov Identifier: NCT00300911     History of Changes
Other Study ID Numbers: KA04/164
Study First Received: March 9, 2006
Last Updated: March 9, 2006
Health Authority: Turkey: Ministry of Health

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Ventricular Dysfunction, Left
Ventricular Dysfunction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Rosiglitazone
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 21, 2014