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
- Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients
研究概览
简要总结
In this study, investigators wanted to determine the effect of T2DM susceptibility gene mutations on self-expression.
Participants (T2DM patients and controls) were recruited to identify genotypes and detect the levels of T2DM susceptibility genes expression in the fresh peripheral plasma. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of T2DM susceptibility genes under different genotypes.
详细描述
The primary objective of this study was to investigate the changes of the expression of T2DM susceptible genes (NOS1AP, KCNQ1, TCF7L2, WSF1, GLP-1R, etc.) in participants (newly diagnosed T2DM patients and controls) after gene mutation.
Secondly, the expression differences of T2DM susceptible genes in T2DM patients with different genotypes were compared, and the relationship between the expression differences and clinicopathological characteristics of T2DM patients was analyzed.
Participants (newly diagnosed T2DM patients and healthy subjects) were screened from the department of endocrinology and health management center, whose fresh peripheral blood were collected. The normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected in the department of general surgery. The DNA genome was extracted for genotyping, and then the expression levels of T2DM related susceptibility genes under different genotypes were detected by ELISA kits, PCR, WB,HE staining, IHC staining, ect.
The basic information of T2DM patients was collected, including demographic characteristics, physiological and biochemical data.Then investigators further compared the differences in the expression of susceptible genes between newly diagnosed T2DM patients and controls.
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
- 是
入选标准
- •no drug therapy; 25 to 70 years old; Hemoglobin A1c (HbA1c) 7%-12%; BMI 20-35 kg/m2; Stable body weight (≤10% change within 3 months)（For newly diagnosed patients with T2DM）.
- •25 to 60 years old; BMI 19-26 kg/m2; in good health, with no abnormalities of motor system, digestive system, respiratory system, urogenital system, blood system, circulatory system, nervous/mental system, endocrine system, etc（For healthy subjects）.
- •20-80 years old; surgical resection of part or all of the pancreas; pancreatic lesions confirmed by enhanced CT or magnetic resonance (MR) examination or confirmed by intraoperative and postoperative pathology（For the patients in general surgical）.
排除标准
- •had taken antidiabetic drugs;
- •had a history of pancreatic surgery;
- •Complicated with severe organ lesions;
- •Long-term use of drugs that affect pancreatic function.
研究组 & 干预措施
Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls
To determine the effect of gene mutations on the susceptibility of T2DM by comparing the expression levels of T2DM susceptibility genes in newly diagnosed T2DM patients and controls.
干预措施: Fresh normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected from controls and T2DM patients without hypoglycemic drugs (Drug)
Comparison of T2DM susceptibility gene expression between newly diagnosed T2DM patients and controls
To determine the effect of gene mutations on the susceptibility of T2DM by comparing the expression levels of T2DM susceptibility genes in newly diagnosed T2DM patients and controls.
干预措施: Fresh blood samples were collected from healthy subjects and T2DM patients without hypoglycemic drugs (Drug)
结局指标
主要结局
Detection of T2DM susceptibility gene expression in newly diagnosed T2DM patients
时间窗: 1 month after fresh sample collection
To detect the expression levels of susceptible genes in the plasma and the pancreatic tissues of newly diagnosed T2DM patients and compared with those in healthy subjects.
Correlation between T2DM susceptibility gene expression and clinicopathological features
时间窗: 6 months after obtaining the clinicopathological results
Incidence of clinical pancreatic diseases under expression differences in T2DM susceptibility genes
Detection of T2DM susceptibility gene expression in controls
时间窗: 1 month after fresh sample collection
To detect the expression levels of susceptible genes in the plasma and the pancreatic tissues of controls and compared with those in newly diagnosed T2DM patients.
次要结局
- Baseline TC of newly diagnosed with T2DM patients with different genotypes(1 month of completion for individual screening)
- Baseline waist hip ratio (WHR) of newly diagnosed with T2DM patients with different genotypes(1 month of completion for individual screening)
- Baseline HbA1c of newly diagnosed with T2DM patients with different genotypes(1 month of completion for individual screening)
- Baseline BMI of newly diagnosed with T2DM patients with different genotypes(1 month of completion for individual screening)
- Baseline fasting plasma glucose (FPG) of newly diagnosed with T2DM patients with different genotypes(1 month of completion for individual screening)
- Baseline HDL-C of controls with different genotypes(1 month of completion for individual screening)
- Baseline LDL-C of newly diagnosed with T2DM patients with different genotypes(1 month of completion for individual screening)
- Baseline WHR of controls with different genotypes(1 month of completion for individual screening)
- Baseline HbA1c of controls with different genotypes(1 month of completion for individual screening)
- Baseline TG of newly diagnosed with T2DM patients with different genotypes(1 month of completion for individual screening)
- Baseline HDL-C of newly diagnosed with T2DM patients with different genotypes(1 month of completion for individual screening)
- Baseline BMI of controls with different genotypes(1 month of completion for individual screening)
- Baseline FPG of controls with different genotypes(1 month of completion for individual screening)
- Baseline TC of controls with different genotypes(1 month of completion for individual screening)
- Baseline TG of controls with different genotypes(1 month of completion for individual screening)
- Baseline LDL-C of controls with different genotypes(1 month of completion for individual screening)