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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01938365

Enrollment

500

Registered

2013-09-10

Start date

2012-01-31

Completion date

2016-12-31

Last updated

2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 30 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Deterioration of pancreatic islet function	3 years

Secondary

Measure	Time frame
Insulin dosage, HbA1c levels and evaluation of chronic complications	3 years

Countries

China

Outcome results