Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449553
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2007-03-01
Brief Title:
Observational Study to Assess Glycosylated Hemoglobin Changes After 6 Months of Treatment With Pioglitazone
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Prospective Study of Associations of Changes in HbA1C and Fasting Blood Lipids Due to Treatment With Pioglitazone for 6 Months and Genetic Polymorphisms in PPAR-gamma
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to asses changes in glycosylated hemoglobin fasting blood lipids and genetic polymorphisms in peroxisomal proliferator activated receptors--gamma receptor after 6 months of pioglitazone once daily QD treatment
Detailed Description:
The metabolic control in type 2 diabetes mellitus can be measured by means of glycosylated hemoglobin A low value glycosylated hemoglobin indicates a good metabolic control and has been shown to be associated with a better prognosis regarding diabetic complications Type 2 diabetes is a disease with a profound genetic component Peroxisome proliferator-activated receptor gamma is a transcription factor implicated in adipocyte differentiation lipid and glucose metabolism Peroxisome proliferator-activated receptor alfa is a transcription factor implicated in lipid oxidation and gluconeogenesis and is present in liver kidney heart skeletal muscle and adipose tissue
Pioglitazone is a thiazolidinedione that targets nuclear peroxisomal proliferator activated receptors members of the super family of ligand activated transcription factors Specifically thiazolidinediones bind to the peroxisome proliferator-activated receptor gamma and affect transcription factors that influence expression of genes responsible for the production of proteins important in carbohydrate and lipoprotein metabolism These include increases in glucose transporters 1 and 4 resulting in enhanced peripheral glucose utilization by fat and skeletal muscle
This is a pharmacoepidemiological study to evaluate whether the individual genotype of the patients have any influence on the efficacy of pioglitazone
Pioglitazone is a thiazolidinedione that targets nuclear peroxisomal proliferator activated receptors members of the super family of ligand activated transcription factors Specifically thiazolidinediones bind to the peroxisome proliferator-activated receptor gamma and affect transcription factors that influence expression of genes responsible for the production of proteins important in carbohydrate and lipoprotein metabolism These include increases in glucose transporters 1 and 4 resulting in enhanced peripheral glucose utilization by fat and skeletal muscle
This is a pharmacoepidemiological study to evaluate whether the individual genotype of the patients have any influence on the efficacy of pioglitazone
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1114-2473 | REGISTRY | WHO | None |