- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00837408
Genetics of Type 2 Diabetes Among Han Chinese
Objectives:
- To conduct a genome-wide association study (GWAS) to identify susceptibility genetic variants for diabetes among Han Chinese.
- To conduct resequencing of positional candidate gene/loci to identify likely functional variants in a subset of the cohort.
- To conduct replication studies of the top-100 scoring variants in three independent African and European ancestry samples.
- To investigate whether diabetes-associated variants discovered in European populations increase diabetes risk in Han Chinese.
Eligibility:
- Patients 25 years of age with newly diagnosed T2D in Suizhou, China. Control subjects are nondiabetics, age and ethnically matched to patients.
Design:
- The study design for both patients and controls consists of the following steps:
- Discuss informed consent process and obtain signed informed consent form. Informed consent will be administered by trained clinic staff.
- Assign study ID (barcode)
- Administer questionnaires
- Obtain spot urine sample
- Measure blood pressure
- Obtain anthropometric measurements including body composition
- Perform finger prick for blood glucose level
- Obtain venous blood samples
- Perform eye examination
- On the following day, perform confirmatory blood glucose for the small subset of participants requiring confirmation of previous test result
- DNA extraction of stored samples will be done at either the National Institutes of Health or the laboratory in China.
- GWAS will be conducted using publicly available software packages.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Suizhou, China
- HuBei Suizhou Central Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Cases
Individuals with Type 2 Diabetes
|
Controls
Individuals without Type 2 Diabetes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Type 2 Diabetes
Time Frame: Cross-sectional
|
Diagnosis of type 2 diabetes based on blood glucose measurement.
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Cross-sectional
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999909071
- 09-HG-N071
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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