Type 2 Diabetes Mellitus Clinical Trial
Official title:
Type 2 Diabetes Mellitus Collaborative Genetic Study Room
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.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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