Genetics of Type 2 Diabetes Among Han Chinese

NCT00837408 | Completed

• 2 other identifiers: 99990907109-HG-N071
• Study Type: observational
• Target: 2,379
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Hypertension

Keywords

GWAS

Outcome Measures

Primary Outcomes (1)

• Type 2 Diabetes

  Diagnosis of type 2 diabetes based on blood glucose measurement.

  Cross-sectional

Study Arms (2)

Cases

Individuals with Type 2 Diabetes

Controls

Individuals without Type 2 Diabetes

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases will be drawn from Type 2 Diabetics attending clinics at the Suizhou Central Hospital. Controls will be ethnicity-matched individuals from the community served by this hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Human Genome Research Institute (NHGRI): lead

Study Sites (1)

HuBei Suizhou Central Hospital

Suizhou, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Charles N Rotimi, M.D.

  National Human Genome Research Institute (NHGRI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 5, 2009
• Study Start: February 3, 2009
• Primary Completion: February 3, 2012
• Study Completion: February 3, 2012
• Last Updated: September 25, 2020

Record last verified: 2020-09

Locations

CN (1)