Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Evaluation of the biomarkers of the epithelial-mesenchymal transition process
研究概览
简要总结
The purpose of the real-world observational prospective study is to access the renoprotective effects of dulaglutide as well as to explore corresponding mechanisms in patients with Type 2 Diabetic Nephropathy.
详细描述
Related studies have found that Glucagon-like peptide-1 (GLP-1) receptors are localized on a variety of tissues and cell types in addition to pancreatic β-cells, and GLP-1 and GLP-1 receptor agonists can exert diverse effect on multiple organs and tissues, with pleiotropic potential physiological, pathophysiological as well as pharmacological implications. Multiple clinical trials suggest that GLP-1 receptor agonists can exert renoprotective effects and persuasively inhibit the progression of kidney disease in type 2 diabetic patients. The beneficial effects of GLP-1 receptor agonists on Type 2 Diabetic Nephropathy, independent of their hypoglycemic ability, might are mediated by anti-oxidative stress, anti-inflammatory and natriuresis properties. However, it is not clear whether the above-mentioned properties are involved in the EMT process of renal tubular epithelial cells.
All participants meeting all eligibility criteria received routine medical consultations. During routine medical visits, patients were randomized into two groups (1.07:1) to receive a total duration of 12 months of hypoglycemic therapy - dulaglutide plus other hypoglycemic agents not including GLP-1 receptor agonists (intervention group), and other hypoglycemic agents not including GLP-1 receptor agonists (control group). A random number method was applied for grouping in this study. Dulaglutide and other hypoglycemic agents were administered according to the drug package insert. Of course, the investigators decided on other background treatments for hypertension, hyperlipidemia, or cardiovascular-related risk factors based on the latest guidelines throughout the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adults aged 18 and above
- •No minors involved in the study
- •Diabetic Nephropathy defined as a urinary albumin-to-creatinine ratio ≥30 mg/g at least twice in three measurements within a period of 3-6 months
排除标准
- •Patients with other types of kidney disease
- •Urinary tract infection
- •Type 1 diabetes
研究组 & 干预措施
Dulaglutide
Dulaglutide was injected subcutaneously at standard dose and frequency for consecutive 12 months.
干预措施: Dulaglutide Injection (Drug)
other hypoglycemic agents not including GLP-1 receptor agonists
Other hypoglycemic agents not including GLP-1 receptor agonists were used at standard dose and frequency for consecutive 12 months.
干预措施: Dulaglutide Injection (Drug)
结局指标
主要结局
Evaluation of the biomarkers of the epithelial-mesenchymal transition process
时间窗: 3,6 and 12 months after dulaglutide injection treatment
the changes in the biomarkers of the epithelial-mesenchymal transition process from the baseline at 3, 6 and 12 months. These biomarkers of the epithelial-mesenchymal transition process include E-cadherin and periostin.
Evaluation of the urinary albumin-to-creatinine ratio
时间窗: 3,6 and 12 months after dulaglutide injection treatment
the changes in the urinary albumin-to-creatinine ratio
次要结局
- Evaluation of the cystatin C(3,6 and 12 months after dulaglutide injection treatment)
- Evaluation of the estimated glomerular filtration rate(3,6 and 12 months after dulaglutide injection treatment)
- Evaluation of adverse event(3,6 and 12 months after dulaglutide injection treatment)
