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临床试验 NCT06256419 针对2型糖尿病，遗传易感性目前招募中。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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卡片视图
基因多态性与T2DM易感性及对Exenatide治疗反应的关联研究，针对中国T2DM患者 300
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临床试验NCT06256419是一项针对2型糖尿病，遗传易感性的干预性研究试验，目前试验状态为招募中。试验始于2024年1月1日，计划招募300名患者。该研究由The Affiliated Hospital of Xuzhou Medical University主导，预计于2028年1月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月18日。
简要概括
This is a retrospective cohort study of patients with T2DM who were treated with exenatide twice daily as a part of their diabetes care for at least 12 months. The objective of this study is to investigate the influence of T2DM susceptibility gene polymorphisms (NOS1AP, KCNQ1, TCF7L2, WSF1, GLP-1R, etc.) on the efficacy of GLP-1 RA (exenatide, liraglutide, etc.), to identify the variables that can predict the efficac...显示更多
详细描述
T2DM is a polygenic genetic disease. The individual differences in the efficacy of antidiabetic drugs are caused by the cumulative effect of multiple gene polymorphisms, and are related to environmental factors and lifestyle. The results of single gene polymorphism cannot fully explain the individual differences in the efficacy of antidiabetic drugs. Verifying the correlation between T2DM gene polymorphisms and the e...显示更多
官方标题
Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
疾病
2型糖尿病遗传易感性其他研究标识符
- XYFY2023-KL479-01
NCT编号
实际开始日期
2024-01-01
最近更新发布
2025-09-18
预计完成日期
2028-01-31
计划入组人数
300
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Type 2 Diabetes Mellitus
GLP-1 RA
gene polymorphism
susceptibility gene
variation
GLP-1 RA
gene polymorphism
susceptibility gene
variation
主要目的
预防
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性efficacy difference of GLP-1RA Responders group and non-responders group | GLP-1 receptor agonist Eligible patients with T2DM were required to have received GLP-1RA as monotherapy or in combination with other antidiabetic agents. GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months in patients with T2DM. responders group and nonresponders group For all the patients with type 2 diabetes who were initially enrolled in the study, blood samples were obtained for genotyping before the administration of GLP-1 receptor agonists. Patients were re-screened according to whether they had used GLP-1 RA continuously for more than 6 months and had completed the specified follow-up tasks.
Patients were divided according to the type of T2DM susceptibility genes. Or all we...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change from baseline HbA1c and baseline weight at 6 month | In order to observe the change from baseline HbA1c and baseline weight at 6 month after GLP-1 RA treatment | 6 month after GLP-1 RA treatment |
To identify and evaluate the variable factors influencing GLP-1 RA efficacy | The variable factors that predict the efficacy of GLP-1 RA were identified and the weight these variables on the efficacy was assessed | 1 month after sample integration |
Genotype identification in patients with T2DM | Blood samples were collected from T2DM patients for genotyping | 1 month after sample collecting |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment | To evaluate the incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment, including gastrointestinal reaction and hypoglycemia | 6 months after GLP-1 RA treatment |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
25 Years
适龄性别
全部
- a diagnosis of T2DM
- a body mass index (BMI) of 20-35 kg/m2
- an HbA1c of 7.0%-12%, an age of 25-70 years
- required data available at baseline and 6 months after GLP-1RA therapy.
- Patients with serious diseases such as acute myocardial infarction, cerebral vascular accident, trauma, kidney or liver diseases, severe gastrointestinal dysfunction, and history of pancreatitis
- patients receiving GLP-1 analogues, weight loss drugs, glucocorticoids, drugs affecting gastrointestinal peristalsis in the past 3 months
- those with missing data at the time points of baseline, 3 months, and 6 months after GLP-1 RA therapy.
The Affiliated Hospital of Xuzhou Medical University研究中心联系人
联系人: Tao Wang, Ph.D, 13815344640, [email protected]
联系人: Xiaoxing Yin, Ph.D, 13605218523, [email protected]
1 位于 1 个国家/地区的研究中心
China
China, Jiangsu, Department of Endocrinology, Xuzhou, China, 221006, China
Hongwei Ling, MD, 联系人, 18052268607, [email protected]
Renguo Chen, MD, 主要研究者
Yuhan Huang, MD, 分研究者
招募中