Genetics of Type 1 Diabetes in Chinese Adolescents and Youth

Shanghai Jiao Tong University School of Medicine

Status: Unknown

Conditions: Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT01938365

CCEMD020

Details and patient eligibility

About

primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and youth.

secondary outcomes:

1. To classify diabetes by gene detection in Chinese adolescent and youth.
2. To make the relationship between genotype and clinic phenotype in type 1 diabetes.
3. To evaluate the effect of environmental factors (intestinal ecosystem)in the pathogenesis of diabetes.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 14 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age: 14- 30 years old
2. Gender: males and females
3. Race: han
4. Diabetes diagnosed by WHO cafeteria (WHO1999)
5. Living in east China area to minimize population stratification

Exclusion criteria

1. Secondary diabetes caused by other diseases or drugs
2. Moderate to severe liver, kidney dysfunction, i.e. ALT/AST > 2.5 times the upper limit of normal range or Ccr < 25ml/min;
3. Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.

Trial design

500 participants in 2 patient groups

Diabetes

Normal glucose regulation