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

NCT ID: NCT00155922

Last Updated: 2006-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Atherosclerosis

Keywords

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Diabetes mellitus Monocyte Gene expression Monocyte gene expression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Wei-Shiung Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wei-Shiung Yang, MD, PhD

Role: CONTACT

Phone: 886-2-2312-3456

Email: [email protected]

Facility Contacts

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Wei-Shiung Yang, MD, PhD

Role: primary

Other Identifiers

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9261700953

Identifier Type: -

Identifier Source: org_study_id