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临床试验/NCT01250639
NCT01250639Unknown不适用

Type 2 Diabetes Mellitus Collaborative Genetic Study Room

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
5,000
试验地点
1

研究概览

简要总结

This study is a cooperative project and aims to identify genetic components associated with type 2 diabetes mellitus (T2DM), which is significant for the population of non-aboriginal Taiwanese.

详细描述

This study is a cooperative project between Academia Sinica (AS), China Medical University Hospital (CMUH) and Chiayi Christian Hospital (CCH) and aims to identify genetic components associated with type 2 diabetes mellitus (T2DM), which is significant for the population of non-aboriginal Taiwanese. AS provides funding, designs the study protocol, and coordinates the project, including subject recruitment, collection of phenotype information and bio-specimen and quality assurance. CMUH and CCH are the study sites and are responsible for subject screening and recruitment, bio-specimen collection and packaging as well as phenotypic information collection. The study objective is to carry out a collaborative association study on T2DM in non-aboriginal Taiwanese.

A genome-wide case-control association study will be adopted. Approximately five thousand of T2DM subjects whose age is equal to or above twenty will be recruited by study physicians in the out-patient-department in CMUH and CCH. In addition, relatives of T2DM subjects with a positive family history, in which at least three family members are affected with T2DM within five generations, will be recruited by study nurses. An age-, sex-, and ethnicity-matched control will be selected randomly from the Cell Bank and Genetic Database on Non-Aboriginal Taiwanese. After obtaining informed consent, the medical history questionnaire and family background will be completed by the subjects. The subjects will be invited for a health check-up which include blood pressure, body weight, body height, waist circumference and hip circumference, as well as an ophthalmic check-up. A 15 ml of blood will be drawn from the subject for measurements of Cholesterol, HDLc, LDLc, TG, Fasting Plasma Glucose, Insulin, HbA1c, CBC without differential count, Electrolytes (Ca2+ , Na+, K+, Cl-), BUN, Creatinine, SGOT, SGPT, C-peptide, Uric Acid and CRP, as well as DNA extraction. A urine sample collection will also be requested from the subject for evaluation of urine protein, ketone body, glucose, micro albumine and creatinine.

This genome-wide association study aims to investigate the disease causing variants/genes of T2DM and diabetic subphenotypes as well as the underlying mechanisms in T2DM pathogenesis. Hopefully, early diagnostic markers and new therapies will be developed based on the genetic etiology and toward the personalized medicine in the future.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 20 years
  • Subject must satisfy the diagnostic criteria for T2D at the time of examination.
  • Subject is willing to participate and capable of giving informed consent.
  • Subject is a self reported non-aboriginal Taiwanese, and none of the parents and grand-parents has aboriginal background.
  • Relatives of T2DM subjects with a positive family history are willing to participate and capable of giving informed consent.

排除标准

  • Type 1 Diabetes
  • Gestational Diabetes
  • Monogenic Diabetes
  • Subject is unable to understand or give informed consent.

研究者

申办方类型
Other

研究点 (1)

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