Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232362
Status:
WITHDRAWN
Last Update Posted:
2015-04-13
First Post:
2005-09-30
Brief Title:
Effect of Pioglitazone on Left Ventricular Diastolic Function in Type 2 Diabetes Mellitus
Sponsor:
Texas Tech University Health Sciences Center
Organization:
Texas Tech University Health Sciences Center
Study Overview
Official Title:
Effect of Pioglitazone on Left Ventricular Diastolic Function in Type 2 Diabetes Mellitus
Status:
WITHDRAWN
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was not conducted as the Principal Investigator left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is being done to determine if pioglitazone Actos is helpful to patients with type 2 diabetes and could possibly prevent harmful consequences of cardiovascular disease in diabetic patients
Detailed Description:
Cross sectional and population-based studies indicate that at least one third of all patients with congestive heart failure CHF have a normal or near normal ejection fraction which is thought to be secondary to diastolic dysfunction or failure The mortality rates among the patients with diastolic failure ranges from 5-8 annually as compared with 10-15 among patients with systolic heart failure The morbidity associated with diastolic heart failure is similar to that of systolic heart failure Several studies have shown that even simple Doppler evidence of diastolic dysfunction is an independent risk factor for the development of CHF and cardiac death and increased all cause mortality Several studies indicate that left ventricular diastolic dysfunction LVDD represent the earliest preclinical manifestation of diabetic cardiomyopathy that can progress to symptomatic heart failure Recent studies have demonstrated up to 60 of asymptomatic normotensive patients with type 2 diabetes have LVDD when assessed by conventional echocardiography including the response to the Valsalva maneuver A recent study using conventional Doppler valsalva maneuver color M-mode echocardiography and tissue doppler imaging assessed the diastolic dysfunction in asymptomatic normotensive patients with diabetes mellitus and found diastolic dysfunction in about 75 of these patients Cardiovascular disease is the leading cause of death in patients with type 2 diabetes mellitus Although diabetic patients have a large number of cardiovascular risk factors like hyperlipidemia and hypertension the diabetic cardiomyopathy occurs independent of these risk factors Recently animal models have shown that LVDD may be prevented by chronic treatment with peroxisome-proliferator-activated receptors gamma PPAR agonists like thiazolidinediones in type 2 diabetic rats Thiazolidinediones act through PPAR but the exact mechanism by which they improve LVDD is not known With this background knowledge we wanted to study the effect of Pioglitazone which is PPAR agonist and partial PPAR agonist on the left ventricular diastolic dysfunction in type 2 diabetic human subjects which has not been studied so far If this therapy proves to have beneficial effect on the LVDD it will help in preventing the deleterious consequences of diastolic dysfunction in diabetic patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None