Genetics of Type 1 Diabetes in Chinese Adolescents and Youth
Study Details
Study Description
Brief Summary
primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and youth.
secondary outcomes:
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To classify diabetes by gene detection in Chinese adolescent and youth.
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To make the relationship between genotype and clinic phenotype in type 1 diabetes.
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To evaluate the effect of environmental factors (intestinal ecosystem)in the pathogenesis of diabetes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
Phase 1: Baseline investigation Aims: To explore genetic susceptibility of diabetes in Chinese adolescent and youth.
Subjects and Methods: 500 patients under diabetic conditions and sex,age-matched NGR Healthy control(2:1) will be enrolled ,all aged from 14-30 years old. A comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis will be performed in each study participant. Diabetes should be diagnosed according to the WHO 1999 criteria,type 1 or type 2 diabetes diagnosed by clinical features recommended by International Society of Pediatric and Adolescent Diabetes ( ISPAD ).
Phase 2: Cohort follow-up Aims : To explore the association of genetic backgrounds and clinical characteristics in different types of diabetes in Chinese adolescent and youth.
Subjects and Methods: To recruit and follow up 200 newly diagnosed and genotyped patients for 3 years. Questionnaire, anthropometric measurements, biochemical analysis performed respectively at baseline,3,6,12,24,36 months after enrollment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Diabetes
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| Normal glucose regulation
|
Outcome Measures
Primary Outcome Measures
- Deterioration of pancreatic islet function [3 years]
Secondary Outcome Measures
- Insulin dosage, HbA1c levels and evaluation of chronic complications [3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 14- 30 years old
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Gender: males and females
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Race: han
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Diabetes diagnosed by WHO cafeteria (WHO1999)
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Living in east China area to minimize population stratification
Exclusion Criteria:
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Secondary diabetes caused by other diseases or drugs
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Moderate to severe liver, kidney dysfunction, i.e. ALT/AST > 2.5 times the upper limit of normal range or Ccr < 25ml/min;
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Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin hospital, Shanghai Jiao-Tong University School of Medicine | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Shanghai Jiao Tong University School of Medicine
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CCEMD020