NCT06746610招募中不适用
Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Genetic landscape of monogenic diabetes mellitus in China
研究概览
简要总结
The goal of this observational study is to establish a registry, screening, and individualized management platform for patients with monogenic diabetes mellitus(MDM) using internet-based and mobile application software. The main questions it aims to answer are:
- What are the genetic mutations causing MDM in China (genetic landscape)?
- How effective and safe is the individualized, molecular-diagnosis-based management platform for MDM in improving patient outcomes?
Participants will:
- Register in the MDM platform via mobile app or internet-based software
- Undergo genetic screening for MDM diagnosis
- Participate in follow-up visits for individualized management and monitoring of blood glucose control and outcomes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes patients who developed before 25 years old; Or they were diagnosed with diabetes before the age of 35, and two or more immediate relatives were diagnosed with diabetes before the age of 45;
- •Body mass index (BMI) at diagnosis < 28 kg/m2;
- •Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;
排除标准
- •Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;
- •Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;
- •Patients with malignant tumors.
结局指标
主要结局
Genetic landscape of monogenic diabetes mellitus in China
时间窗: 24 months
次要结局
未报告次要终点
研究者
Hua Shu
Attending Physician
Tianjin Medical University General Hospital
研究点 (1)
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