Genetics of Type 1 Diabetes in Chinese Adolescents and Youth
|ClinicalTrials.gov Identifier: NCT01938365|
Recruitment Status : Unknown
Verified November 2013 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : September 10, 2013
Last Update Posted : November 13, 2013
primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and youth.
- 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.
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||A Prospective Cohort Study of Clinical Characteristics and Genetic Susceptibility of Type 1 Diabetes in Chinese Adolescents and Youth|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2016|
|Normal glucose regulation|
- Deterioration of pancreatic islet function [ Time Frame: 3 years ]
- Insulin dosage, HbA1c levels and evaluation of chronic complications [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938365
|Ruijin hospital, Shanghai Jiao-Tong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200025|
|Contact: Guang Ning, Professor 8621-64370045 ext 665344 firstname.lastname@example.org|
|Principal Investigator: Guang Ning, Professor|