Trial record 3 of 1626 for:    type 2 diabetes | Open Studies

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Academia Sinica, Taiwan
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01250639
First received: November 29, 2010
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

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.


Condition
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Type 2 Diabetes Mellitus Collaborative Genetic Study Room

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Biospecimen Retention:   Samples With DNA

serum,urine


Estimated Enrollment: 5000
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Type 2 Diabetes Mellitus

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250639

Contacts
Contact: Fuu-Jen Tsai, PHD 866-4-22052121 ext 2041 yhliang@mail.cmuh.org.tw

Locations
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Fuu-Jen Tsai, PHD    886-4-22052121 ext 2041    yhliang@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
Academia Sinica, Taiwan
Investigators
Principal Investigator: Fuu-Jen Tsai, PHD Division of Metabolism and Endocrinology
  More Information

No publications provided

Responsible Party: Division of Metabolism and Endocrinology, Fuu-Jen Tsai
ClinicalTrials.gov Identifier: NCT01250639     History of Changes
Other Study ID Numbers: DMR99-IRB-164
Study First Received: November 29, 2010
Last Updated: November 30, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
Type 2 Diabetes Mellitus
non-aboriginal Taiwanese
Genome-wide association study

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014