Clinical trial NCT00300911: Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction
Official title: A Study of PPAR-Gamma Agonist-Rosiglitazone for Determining Cardiac Adverse Effects in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Natriuretic Peptide, Brain
Heart Failure, Congestive
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2006-03-10
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Plasma Brain Natriuretic Peptide levels, echocardiographic measurements were made before the treatment and repeated after three months and six months of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
Study officials:
affiliation: Medical Doctor, Internal Medicine
name: Yasemin T Kemal, MD
role: STUDY_DIRECTOR
References:
citation: Niemeyer NV, Janney LM. Thiazolidinedione-induced edema. Pharmacotherapy. 2002 Jul;22(7):924-9. doi: 10.1592/phco.22.11.924.33626.
citation: Wooltorton E. Rosiglitazone (Avandia) and pioglitazone (Actos) and heart failure. CMAJ. 2002 Jan 22;166(2):219. No abstract available.
citation: Idris I, Gray S, Donnelly R. Rosiglitazone and pulmonary oedema: an acute dose-dependent effect on human endothelial cell permeability. Diabetologia. 2003 Feb;46(2):288-90. doi: 10.1007/s00125-002-1008-1. Epub 2003 Feb 12.
citation: Maeda K, Tsutamoto T, Wada A, Hisanaga T, Kinoshita M. Plasma brain natriuretic peptide as a biochemical marker of high left ventricular end-diastolic pressure in patients with symptomatic left ventricular dysfunction. Am Heart J. 1998 May;135(5 Pt 1):825-32. doi: 10.1016/s0002-8703(98)70041-9.
citation: Lubien E, DeMaria A, Krishnaswamy P, Clopton P, Koon J, Kazanegra R, Gardetto N, Wanner E, Maisel AS. Utility of B-natriuretic peptide in detecting diastolic dysfunction: comparison with Doppler velocity recordings. Circulation. 2002 Feb 5;105(5):595-601. doi: 10.1161/hc0502.103010.
citation: Ogawa S, Takeuchi K, Ito S. Plasma BNP levels in the treatment of type 2 diabetes with pioglitazone. J Clin Endocrinol Metab. 2003 Aug;88(8):3993-6. doi: 10.1210/jc.2002-021765.