Viewing Study NCT00155922



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00155922
Status: UNKNOWN
Last Update Posted: 2006-12-14
First Post: 2005-09-09

Brief Title: The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients Special Relevance to Atherosclerosis
Status: UNKNOWN
Status Verified Date: 2005-09
Last Known Status: RECRUITING
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 investigators hypothesize that macrophages play a crucial role in the pathogenesis of atherosclerosis in patients with type 2 diabetes mellitus T2DM
Detailed Description: Cardiovascular events are the leading cause of death in developed countries worldwide including Taiwan Type 2 diabetes mellitus T2DM previously considered merely as one of the risk factors has been recently unanimously accepted to be coronary artery disease-equivalent How T2DM may lead to accelerated atherosclerosis remains obscure

Hyperglycemia with or without hyperinsulinemia may lead to higher oxidative stress and generalized inflammation The oxidative stress and inflammation may play a significant role in the pathogenesis in diabetic complications including micro- and macro-vascular complications Macrophages together with T-lymphocytes are the earliest cell-types found in fatty-streaks the earliest atherosclerotic lesions Macrophages are also well known cellular mediators of oxidative stress and inflammation Therefore it is plausible to hypothesize that macrophages play a crucial role in the pathogenesis of atherosclerosis in patients with T2DM In addition the other cell types of the peripheral white blood cells WBC such as neutrophils have been shown to be intimately related to acute coronary syndrome Therefore the study on the biology of peripheral WBCs may tell us something about the pathophysiology of diabetic macro-vascular complications

Methods

1 Normal control fasting plasma glucose FPG less than 126 mgdl
2 T2DM FPG 126 mgdl

Group 1 good glycemic control hemoglobin A1c HbA1c 7 in the past 6 months
Group 2 poor glycemic control HbA1c 8 in the past 6 months
3 Blood sample will be collected at baseline and after aggressive control

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