Diabetes Mellitus Clinical Trial
Official title:
A Prospective Cohort Study of Clinical Characteristics and Genetic Susceptibility of Type 1 Diabetes in Chinese Adolescents and Youth
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.
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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