The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

December 13, 2006

Start Date ^†

November 2003

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00155922 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients

Official Title ^†

The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients, Special Relevance to Atherosclerosis

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:

Normal control: fasting plasma glucose (FPG) less than 126 mg/dl.
T2DM: FPG ＞＝126 mg/dl.
- 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
Blood sample will be collected at baseline and after aggressive control.

Study Phase

Study Type ^†

Observational

Study Design ^†

Natural History, Longitudinal, Case Control, Prospective Study

Condition ^†

Diabetes Mellitus, Type 2
Atherosclerosis

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

100

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Normal control: fasting plasma glucose (FPG) less than 126 mg/dl.
T2DM: FPG ＞＝126 mg/dl.
- Group 1 (good glycemic control): HbA1c＜＝7% in the past 6 months
- Group 2 (poor glycemic control): HbA1c＞＝8% in the past 6 months

Exclusion Criteria:

Acute systemic diseases

Gender

Both

Ages

25 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Wei-Shiung Yang, MD, PhD

886-2-2312-3456 ext 7258

wsyang@ha.mc.ntu.edu.tw

Location Countries ^†

Taiwan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00155922

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

National Taiwan University Hospital

Collaborators ^††

Investigators ^†

Principal Investigator:

Wei-Shiung Yang, MD, PhD

National Taiwan University Hospital

Information Provided By

National Taiwan University Hospital

Verification Date

September 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.