NCT01938365

Genetics of Type 1 Diabetes in Chinese Adolescents and Youth

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 14 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-12-01
• Completion: 2016-12-01
• First posted: 2013-09-10
• Last updated: 2013-11-13

Locations

1 site across 1 country: China