Genetics of Type 1 Diabetes in Chinese Adolescents and Youth
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|