A Prospective Cohort Study of Clinical Characteristics and Genetic Susceptibility of Type 1 Diabetes in Chinese Adolescents and Youth
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Deterioration of pancreatic islet function
研究概览
简要总结
primary outcome: To explore the genetic susceptibility of diabetes in Chinese adolescent and youth.
secondary outcomes:
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 14- 30 years old
- •Gender: males and females
- •Diabetes diagnosed by WHO cafeteria (WHO1999)
- •Living in east China area to minimize population stratification
排除标准
- •Secondary diabetes caused by other diseases or drugs
- •Moderate to severe liver, kidney dysfunction, i.e. ALT/AST > 2.5 times the upper limit of normal range or Ccr < 25ml/min;
- •Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
结局指标
主要结局
Deterioration of pancreatic islet function
时间窗: 3 years
次要结局
- Insulin dosage, HbA1c levels and evaluation of chronic complications(3 years)
研究者
Guang Ning
Professor
Shanghai Jiao Tong University School of Medicine