Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change from baseline HbA1c and baseline weight at 6 month
研究概览
简要总结
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 efficacy of GLP-1 RA, and to evaluate the weight of these variables on the efficacy.
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 efficacy of antidiabetic drugs, clarifying the genetic determinants of individual differences in the efficacy of antidiabetic drugs, and predicting the efficacy and side effects of antidiabetic drugs are of great significance for the formulation of precise medication regimens for T2DM patients.
Many guidelines recommend the preferential use of GLP-1 RA after single drug or multiple oral hypoglycemic drugs and basic insulin therapy for poor glycemic control. However, the clinical responsiveness to GLP-1 RA varies among patients with T2DM. It has been reported that genetic factors are the important reasons for individual variation in therapeutic response of antidiabetic drugs. At present, dozens of gene loci related to therapeutic response of antidiabetic drugs have been screened, which are of great clinical significance in guiding clinical individualized treatment, improving the efficacy and safety of drugs, and reducing the drug costs.
GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months. The patients were visited at moths 0, 3, and 6, and medical histories, physical examinations, and routine clinical laboratory tests were performed during these visits. The general anthropometric parameters considered for this study were height (m), weight (kg), and waist and hip circumferences (cm) at baseline, 3 months and 6months after exenatide treatment.
Patients who had an HbA1c reduction ≥1.0% or HbA1c <7.0% after exenatide treatment for six consecutive months were considered responders, while patients who failed to achieve this decrease were considered non-responders. The clinical data were collected and analyzed to determine the variables that could predict the efficacy of GLP-1 RA, and to evaluate the weight of the influence of these variables on the efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
efficacy difference of GLP-1RA
Responders group and non-responders group
干预措施: GLP-1 receptor agonist (Drug)
efficacy difference of GLP-1RA
Responders group and non-responders group
干预措施: responders group and nonresponders group (Drug)
结局指标
主要结局
Change from baseline HbA1c and baseline weight at 6 month
时间窗: 6 month after GLP-1 RA treatment
In order to observe the change from baseline HbA1c and baseline weight at 6 month after GLP-1 RA treatment
Genotype identification in patients with T2DM
时间窗: 1 month after sample collecting
Blood samples were collected from T2DM patients for genotyping
To identify and evaluate the variable factors influencing GLP-1 RA efficacy
时间窗: 1 month after sample integration
The variable factors that predict the efficacy of GLP-1 RA were identified and the weight these variables on the efficacy was assessed
次要结局
- Incidence and severity of possible adverse reaction within 6 month after GLP-1 RA treatment(6 months after GLP-1 RA treatment)