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临床试验/NCT03399565
NCT03399565Unknown不适用

Children and Adolescent Registry for Diabetes Study in Jiangxi

Second Affiliated Hospital of Nanchang University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年1月18日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
LDL-C

研究概览

简要总结

This study aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life.

详细描述

Background:With the development of economy and the improvement of people's living standards, the incidence of childhood diabetes is rapidly increasing.The multicenter, prospective,retrospectively in children and adolescents registry for diabetes in jiangxi aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life.

Methods:The province's multi-center, prospective、retrospective study, the number of cases planned to be included in 300 cases.The inclusion criteria:A diagnosis of diabetes;reported for diabetes by parents and patients or by doctors and medical records to prove all of the patients;0-30 years old, gender not limited;voluntary participation and sign a consent form.Exclusion criteria

:At the same time, other test drugs or are other clinical trials;Due to other reasons, the researchers think that the person doesn't fit into the group;Diabetes during pregnancy;Besides diabetes diagnosis of tumor, cardiovascular disease and other interfere with the results of the study of disease.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
1 Day 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 1 days to 30 years who were diagnosed with diabetes according to the World Health Organization criteria;
  • Gender is not limited.

排除标准

  • Gestational diabetes mellitus;
  • Patients with malignant tumor,cardiovascular disease and other interference with the results of the study of the disease.
  • Patients are participating in any other clinical studies;

结局指标

主要结局

LDL-C

时间窗: About 3 months after the visit

LDL-C\<2.6mmol/L

HbA1C

时间窗: About 3 months after the visit

HbA1c \<7%

blood pressure

时间窗: About 3 months after the visit

systolic blood pressure \<130mm Hg, diastolic blood pressure\<80mmHg

TC

时间窗: About 3 months after the visit

TC\<5.2mmol/L

TG

时间窗: About 3 months after the visit

TG\<1.7mmol/L

HDL-C

时间窗: About 3 months after the visit

HDL-C\>1.0mmol/L

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital of Nanchang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

YunFeng Shen

professor

Second Affiliated Hospital of Nanchang University

研究点 (1)

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