Genetics of Type 1 Diabetes in Chinese Adolescents and Youth

Study Overview
=================
Brief Summary
-----------------
primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and youth. secondary outcomes: To classify diabetes by gene detection in Chinese adolescent and youth. To make the relationship between genotype and clinic phenotype in type 1 diabetes. To evaluate the effect of environmental factors (intestinal ecosystem)in the pathogenesis of diabetes.

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.

Official Title
-----------------
A Prospective Cohort Study of Clinical Characteristics and Genetic Susceptibility of Type 1 Diabetes in Chinese Adolescents and Youth

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 14- 30 years old Gender: males and females Race: han Diabetes diagnosed by WHO cafeteria (WHO1999) Living in east China area to minimize population stratification Exclusion Criteria: Secondary diabetes caused by other diseases or drugs Moderate to severe liver, kidney dysfunction, i.e. ALT/AST > 2.5 times the upper limit of normal range or Ccr < 25ml/min; Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes<br> | |
| Normal glucose regulation<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deterioration of pancreatic islet function |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin dosage, HbA1c levels and evaluation of chronic complications |  | 3 years |