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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155922
First received: September 9, 2005
Last updated: December 13, 2006
Last verified: September 2005

September 9, 2005
December 13, 2006
November 2003
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00155922 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients
The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients, Special Relevance to Atherosclerosis

The investigators hypothesize that macrophages play a crucial role in the pathogenesis of atherosclerosis in patients with type 2 diabetes mellitus (T2DM).

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 mg/dl.
  2. 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
  3. Blood sample will be collected at baseline and after aggressive control.
Observational
Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
  • Diabetes Mellitus, Type 2
  • Atherosclerosis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
Not Provided

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
Both
25 Years to 65 Years
Yes
Contact: Wei-Shiung Yang, MD, PhD 886-2-2312-3456 ext 7258 wsyang@ha.mc.ntu.edu.tw
Taiwan
 
NCT00155922
9261700953
Not Provided
Not Provided
National Taiwan University Hospital
Not Provided
Principal Investigator: Wei-Shiung Yang, MD, PhD National Taiwan University Hospital
National Taiwan University Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP