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Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Registration Number
NCT00300911
Lead Sponsor
Baskent University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
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
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Plasma Brain Natriuretic Peptide levels, echocardiographic measurements were made before the treatment and repeated after three months and six months of the treatment
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Baskent University Ankara Hospital

🇹🇷

Ankara, Turkey

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