Genetics of Type 2 Diabetes Among Han Chinese
|First Received Date ICMJE||February 4, 2009|
|Last Updated Date||December 19, 2012|
|Start Date ICMJE||January 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00837408 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Genetics of Type 2 Diabetes Among Han Chinese|
|Official Title ICMJE||Genetics of Type 2 Diabetes Among Han Chinese|
This research protocol is designed to study the genetic basis of Type 2 Diabetes (T2D) in Han Chinese. This project taking place at Suizhou Central Hospital complements several years of similar research activities conducted by Dr. Rotimi's lab in populations of the African Diaspora with study sites in Nigeria, Ghana, Kenya and the US. Suizhou Hospital was selected because of the existence of an excellent team of research investigators, infrastructure and more importantly, the availability of a large population from which to enroll and examine persons with diabetes and normal controls. Previous funding from Dr. Rotimi's lab at Howard University made it possible for Dr. Jiang and staff to enroll 1000 cases and controls. Therefore, the goal of the current project is to enroll additional 1500 cases of T2D and 1500 ethnically matched Han controls from Suizhou to facilitate the conduct of genome-wide association study (GWAS) and candidate gene/loci studies in Han, Chinese. The current project will increase the number of subjects for future GWAS, linkage disequilibrium (LD) mapping and functional studies to over 4,000 ethnically balanced cases (greater than 2,000) and controls (greater than 2,000). Identified candidate genes/loci will be investigated by re-sequencing and functional studies will be conducted to identify susceptibility variants for diabetes and associated complications including obesity, hypertension, nephropathy, neuropathy and retinopathy. Given past activities, it is also anticipated that this resource will form the basis of multiple collaborations between Dr. Rotimi's lab, several NIH intramural researchers and non-NIH scientists.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||3000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Cases - Men and women with confirmed type 2 diabetes mellitus that are either on treatment for diabetes or newly diagnose with blood sugar reading on more than one occasion exceeding or equal to 126 mg/dl. These persons must be above the age of 25 years. In this regard, all newly diagnosed participants will be required to visit the clinic on the following day to perform fasting blood glucose test to confirm previous results.
Controls - Men and women with fasting plasma glucose (FPG) less than 100 mg/dl (5.6 mmol/l). Controls must be above age 25 years and should be ethnically matched to the cases. Enrolled cases and controls have to be unrelated. Therefore, only one person may be enrolled from each family unless they are husband and wife.
Attempts will be made to enroll an equal number of men and women. To ensure that ethnic distribution is maintained in the parent study, we are proposing to enroll only Han Chinese participants.
People who do not meet the above criteria (e.g., younger than 24, without the blood sugar requirements, etc). No more than one non-spouse member of each family. No prisoners, pregnant women or fetuses will be included in this study.
|Ages||26 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||China|
|NCT Number ICMJE||NCT00837408|
|Other Study ID Numbers ICMJE||999909071, 09-HG-N071|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Human Genome Research Institute (NHGRI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP