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临床试验/NCT06182891
NCT06182891已完成不适用

Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University

The Affiliated Hospital of Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年10月30日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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