Cohort Study of Patients With Type 1 Diabetes：Clarifing the Underlying Hereditary and Autoimmune Pathogenic Factors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,110
- 试验地点
- 1
- 主要终点
- Effects of structured education on β-cell endocrine function progression of T1D patients.
研究概览
简要总结
This study aims to clarify the underlying hereditary and autoimmune factors that contribute to clinical type 1 diabetes and gain a better understanding of the natural history of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes diagnosed according to the report of WHO (World Health Organization) in 1999;
- •insulin dependence from disease onset,thus diagnosed with type 1 diabetes;
- •all patients gave informed consent to participate in the study and the protocol was approved by the Research Ethics Committee in second Xiangya hospital, Central South University.
排除标准
- •secondary diabetes mellitus;
- •pregnant women;
- •malignant disease.
结局指标
主要结局
Effects of structured education on β-cell endocrine function progression of T1D patients.
时间窗: Baseline and every three months afterwards.
The natural progression of patients' β-cell endocrine functions was assessed by fasting C-peptide (FCP) and postprandial C-peptide (PCP) at each visit. FCP and PCP levels were measured at initial recruitment and every three months after that. The decay rate of β-cell endocrine function of patients in the two groups were compared. Serum C-peptide levels were measured by a chemiluminescence method using a commercial available kit (Adiva Centaur System, Siemens, Germany).
次要结局
- Effects of structured education on blood sugar control.(Baseline and every three months afterwards.)
- Effects of structured education on metabolic control.(Baseline and every three months afterwards.)
研究者
Zhiguang Zhou
Professor,Institute of Metabolism and Endocrinology, The Second Xiangya Hospital and the Diabetes Center, Key Laboratory of Diabetes Immunology, Ministry of Education, Central South University, National Clinical Research Center for Metabolic Diseases.
Second Xiangya Hospital of Central South University