Genetics of Type 1 Diabetes in Chinese Adolescents and Youth

• Conditions: Diabetes Mellitus

• Registration Number: NCT01938365
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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.

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13
• Primary Completion: 2014-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Deterioration of pancreatic islet function	3 years

Secondary Outcome Measures

Name	Time	Method
Insulin dosage, HbA1c levels and evaluation of chronic complications	3 years

Trial Locations

Locations (1)

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China