- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00155922
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
Study Overview
Status
Conditions
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 Type
Enrollment
Contacts and Locations
Study Locations
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Taipei, Taiwan, 10012
- Recruiting
- National Taiwan University Hospital
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Contact:
- Wei-Shiung Yang, MD, PhD
- Phone Number: 7258 886-2-23123456
- Email: wsyang@ha.mc.ntu.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Wei-Shiung Yang, MD, PhD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9261700953
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