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临床试验/NCT04282577
NCT04282577Unknown不适用

Urinary Nephrin and Alpha One Microglobulin as Early Renal Injury Biomarkers in Patients With Inflammatory Bowel Disease

Assiut University0 个研究点目标入组 100 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Early detection of renal injury in patients diagnosed to have inflammatory bowel disease with normal kidney function

研究概览

简要总结

The study aims to early detection of renal injury in patients diagnosed to have inflammatory bowel disease with normal kidney function test focusing on glomerular filtration barrier injury and tubular injury and it's relation to disease activity so precautions could be taken properly to prevent further renal injury later on .

详细描述

Inflammatory bowel disease (IBD) is a chronic and relapsing inflammatory condition of the gastrointestinal tract. Crohn's disease and ulcerative colitis are the two principal types of IBD. The prevalence of IBD has been increasing worldwide . Extraintestinal manifestations of IBD are common, occurring in 6% to 47% of patients involving nearly every organ system .

Renal and urinary system involvement are common in IBD patients with incidence varying from 4% to 23% and is greater in patients with more severe and long-standing disease. Apart from secondary complications, such as nephrolithiasis, hydronephrosis and amyloidosis, other disorders have also been reported. Membranous glomerulonephritis, rapidly progressive glomerulonephritis, mesangiocapillary glomerulonephritis, IgA nephropathy, thin basement membrane disease and kidney granuloma found to be connected with IBD. In addition, non-specific morphological changes in the glomeruli of patients with IBD, like podocyte effacement and mesangial deposition of immunoglobulin and complement have been well documented. Cases of interstitial nephritis reported to be attributed to the nephrotoxic effect of aminosalicylates which used in IBD treatment.

Alpha one microglobulin is a relatively small protein that undergoes glomerular filtration followed by reabsorption and catabolism in the proximal tubules. Increased urinary α1-microglobulin concentration therefore provides an index of proximal tubule dysfunction .

Glomerular filtration barrier related protein changes have not been closely investigated in IBD patients . Nephrin is podocyte-associated protein that play key roles in maintaining the structural and functional integrity of the kidney's filtration barrier. The shedding of nephrin reflects compromisation of podocytes' functional and structural integrity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed to have inflammatory bowel disease (ulcerative colitis or chron's disease )with age more than 18 years and normal kidney function test

排除标准

  • Patients known to have renal disease due to other causes . Diabetic patients . Hypertensive patients

结局指标

主要结局

Early detection of renal injury in patients diagnosed to have inflammatory bowel disease with normal kidney function

时间窗: baseline

using urinary biomarkers (nephrin and alpha one microglobulin ) for early detection of renal injury in inflammatory bowel disease patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noha Gamal Abdelmalik

assistant lecturer

Assiut University

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