Type 2 Diabetes Mellitus Collaborative Genetic Study on Non-aboriginal Taiwanese (T2D2)

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital
    • Contact: Fuu-Jen Tsai, PHD; Phone Number: 2041 886-4-22052121; Email: yhliang@mail.cmuh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Type 2 Diabetes Mellitus

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Collaborators: Academia Sinica, Taiwan
• Investigators: Principal Investigator: Fuu-Jen Tsai, PHD, Division of Metabolism and Endocrinology

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: November 30, 2010
• First Posted (Estimate): December 1, 2010

Study Record Updates

• Last Update Posted (Estimate): December 1, 2010
• Last Update Submitted That Met QC Criteria: November 30, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; non-aboriginal Taiwanese; Genome-wide association study
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: DMR99-IRB-164

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No