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

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ClinicalTrials.gov Identifier: NCT00155922
Recruitment Status : Unknown
Verified September 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : December 14, 2006
Sponsor:
Information provided by:
National Taiwan University Hospital

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

Condition or disease
Diabetes Mellitus, Type 2 Atherosclerosis

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 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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients, Special Relevance to Atherosclerosis
Study Start Date : November 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155922


Contacts
Contact: Wei-Shiung Yang, MD, PhD 886-2-2312-3456 ext 7258 wsyang@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10012
Contact: Wei-Shiung Yang, MD, PhD    886-2-23123456 ext 7258    wsyang@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wei-Shiung Yang, MD, PhD National Taiwan University Hospital

ClinicalTrials.gov Identifier: NCT00155922     History of Changes
Other Study ID Numbers: 9261700953
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 14, 2006
Last Verified: September 2005

Keywords provided by National Taiwan University Hospital:
Diabetes mellitus
Monocyte
Gene expression
Monocyte gene expression

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Atherosclerosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases