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临床试验 NCT05498974 针对1型糖尿病，糖尿病目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes 20,000 儿科 青少年
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临床试验NCT05498974是一项针对1型糖尿病，糖尿病的观察研究试验，目前试验状态为招募中。试验始于2022年1月1日，计划招募20,000名患者。该研究由Second Xiangya Hospital of Central South University主导，预计于2035年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2022年8月12日。
简要概括
The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study in patients with T1D and in pediatric adolescent patients with diabetes who had an age of onset <= 20 years.
CD1S compromises a retrospective study enrolling inpatients hospitalized from Jan 1st, 2016 to Dec 31, 2021, and a prospective study beginning from the year 2022.
详细描述
The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study to investigate the demographic characteristics, metabolic control, complications occurrence as well as risk factors of patients with T1D, and to investigate the clinical features, complications' burdens and risk factors in pediatric adolescent patients with diabetes who had an age of onset <= 20 years.
官方标题
China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes
疾病
1型糖尿病糖尿病其他研究标识符
- CD1S
NCT编号
实际开始日期
2022-01-01
最近更新发布
2022-08-12
预计完成日期
2035-12-31
计划入组人数
20,000
研究类型
观察研究
试验状态
招募中
关键词
Type 1 diabetes; Diabetes in Young
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Individuals diagnosed with type 1 diabetes All patients diagnosed with type 1 diabetes of all ages. | Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center |
Individuals with diabetes who had an age of onset <= 20 years. All patients with diabetes who had an age of onset \<= 20 years. | Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center Standard type 1 diabetes management model constructed by China Alliance for Type 1 Diabetes in each center |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in serum hemoglobin A1c level | A1c reflects the average blood glucose level | Every year for up to 10 years |
Albumin-to-creatinine ratio in urine sample | Albumin-to-creatinine ratio in urine sample | up to 10 years |
Arteriosclerotic cardiovascular diseases | Incident cases of cardiovascular diseases | up to 10 years |
Electromyography | value of nerve conduction velocity, F wave index, H-reflex | up to 10 years |
PHQ-9 | PHQ-9（a score between 0-27, ≥10 may indicate depression) | up to 10 years |
GAD-7 | GAD-7(a score between 0-21, ≥5 may indicate general anxiety) | up to 10 years |
WHO-5 | WHO-5 (a score between 0-100, higher score means better outcome) | up to 10 years |
PAID | PAID (a score between 0-100, ≥40 warrants special attention). | up to 10 years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in C-peptide | C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study | Every year for up to 10 years |
Change in titer of autoantibodies | Glutamic acid decarboxylase antibody | Every year for up to 10 years |
Fasting blood glucose | the blood sugar level after fasting for eight hours | Every year for up to 10 years |
Systolic blood pressure | Systolic blood pressure | Every year for up to 10 years |
Diastolic blood pressure | Diastolic blood pressure | Every year for up to 10 years |
Change in lipid profiles | Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol | Every year for up to 10 years |
Metabolomics | un-targeted metabolomics | Every year for up to 10 years |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
适龄性别
全部
1. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3)
- Clinical diagnosis of type 1 diabetes by a specialist
- Age at onset < 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide < 200 pmol/L
- Initiation and continuation of insulin therapy (except pancreatic or islet transplantation) after diagnosis; positive islet autoantibodies Or 2. Children and adolescents with diabetes mellitus at age of onset <= 20 years, regardless of type and duration of disease.
For enrolment of patients with T1D, exclusion was made if any of the following criteria were met (not applicable to those with onset under 20 years of age)
No insulin dependence for at least 6 months after diagnosis of diabetes mellitus.
- No DKA for 1 month off insulin for those with a history of diabetes > 1 year. ③ C-peptide > 800 pmol/L at any time point.
Second Xiangya Hospital of Central South University研究责任方
Zhiguang Zhou, 主要研究者, Director, National Clinical Research Center for Metabolic Diseases, Second Xiangya Hospital of Central South University
研究中心联系人
联系人: Zhiguang Zhou, MD, PhD, +8673185292154, [email protected]
联系人: Xia Li, MD, PhD, [email protected]
11 位于 1 个国家/地区的研究中心
Gansu
Gansu Provincial People's Hospital, Lanzhou, Gansu, China
Jing Liu, 联系人
招募中
Guangdong
Shenzhen Second People's Hospital, Shenzhen, Guangdong, China
Dewen Yan, 联系人
招募中
Hainan
Hainan General Hospital, Haikou, Hainan, 570311, China
Huibiao Quan, 联系人
招募中
Heilongjiang
the First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
Hongyu Kuang, 联系人
招募中
Henan
The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, Henan, China
Hongwei Jiang, 联系人
招募中
Hunan
The Second Xiangya Hospital, Central South University, Changsha, Hunan, 410000, China
Xia Li, MD, PhD, 联系人, [email protected]
招募中
Jiangsu
The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China
Tao Yang, 联系人
尚未招募
Shanxi
Heji Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China
Xiaohong Niu, 联系人
招募中
Xinjiang
The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, 830017, China
Sheng Jiang, 联系人
招募中
Yunnan
The First People's Hospital of Yunnan, Kunming, Yunnan, China
Heng Su, 联系人
招募中
Zhejiang
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
Xiaohong Wu, 联系人
招募中