Clinical trial NCT01250639: Type 2 Diabetes Mellitus Collaborative Genetic Study on Non-aboriginal Taiwanese
Official title: Type 2 Diabetes Mellitus Collaborative Genetic Study Room
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
non-aboriginal Taiwanese
Genome-wide association study
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Academia Sinica, Taiwan
First posted: 2010-12-01
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 Diabetes Mellitus

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Division of Metabolism and Endocrinology
name: Fuu-Jen Tsai, PHD
role: PRINCIPAL_INVESTIGATOR
References: