Genetics of Type 1 Diabetes in Chinese Adolescents and Youth

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01938365
• Other study ID #: CCEMD020
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2013
• Last updated: November 11, 2013
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: November 2013
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 30 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
China	Ruijin hospital, Shanghai Jiao-Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deterioration of pancreatic islet function		3 years	No
Secondary	Insulin dosage, HbA1c levels and evaluation of chronic complications		3 years	No