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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00300911

Enrollment

Registered

2006-03-10

Start date

2005-12-31

Completion date

Unknown

Last updated

2006-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Natriuretic Peptide, Brain, Heart Failure, Congestive

Brief summary

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

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.

Interventions

DRUGRosiglitazone(drug), cardiac adverse effects

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Plasma Brain Natriuretic Peptide levels, echocardiographic measurements were made before the treatment and repeated after three months and six months of the treatment	—

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026