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临床试验/NCT03972098
NCT03972098已完成不适用

Uromodulin Levels in Rheumatoid Arthritis

neval aksoy1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
C.Acute-phase reactants (at least 1 test result is needed for classification)

研究概览

简要总结

The aim of the present study was to evaluate the levels of uromodulin in rheumatoid arthritis (RA) and to investigate whether it was correlated with baseline clinical characteristics. In addition CKD epi,MDRD,urine microalbuminuria,pH,serum urea, creatinine,CRP (C-Reactive protein) were measured.The participants consist of ; %68 patients,% 32 control group.

详细描述

Uromodulin, also known as Tamm-Horsfall protein, is a protein abundantly excreted in the urine in healthy individuals. It is synthesized in the thick ascending limb of Henle (TALH) and the early distal convoluted tubule. Its biologic function is still obscure; however, some experimental studies indicated that it might serve as an important urinary defense factor against bacterial colonization and stone formation.

There are controversial publications on the frequencies of urinary tract infections and nephrolithiasis in patients with mutations of uromodulin gene. Deposition of mutated uromodulin in the urinary system may lead to tubular cell dysfunction and apoptosis. These alterations may subsequently cause tubular atrophy and interstitial fibrosis . Moreover, the release of abnormal uromodulin after apoptosis through basolateral secretion may elicit an immune response which may give rise to an immune-mediated tubulointerstitial nephritis .

Uromodulin can activate the other components of the immune system and may modulate the inflammatory and immune responses through different mechanisms .

Experimental studies yielded that uromodulin negative mice displayed splenomegaly with infiltration of white pulp by macrophages and increased levels of TNF-α and interleukin-1 . Rheumatoid arthritis is a systemic autoimmune condition that may eventually result in the joint damage, disability and premature mortality.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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 who diagnosed of rheumatoid arthritis as criteria of ACR/EULAR
  • All patients age range is 18-80 years.
  • Exclusion Criteria :
  • Renal failure
  • Hepatic insufficiency
  • Diabetes mellitus
  • Other collagen vascular diseases,
  • History of smoking and consumption of alcohol

排除标准

  • 未提供

结局指标

主要结局

C.Acute-phase reactants (at least 1 test result is needed for classification)

时间窗: 1 day

Normal CRP (C-reactive protein and normal) and normal ESR (erythrocyte sedimentation rate) (score 0) Abnormal CRP or abnormal ESR (score1)

Patients with rheumatoid arthritis

时间窗: 1 day

The diagnosis of RA was based on the criteria the American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) in 2010. Patients selected 1. have at least 1 joint with definite clinical synovitis (swelling) 2. with the synovitis not better explained by another disease Classification criteria for RA (score-based algorithm: add score of categories A-D; a score of \>6/10 is needed for classification of a patient as having definite RA)

A.joint involvement

时间窗: 1 day

1 large joint (score 0) 2-10 large joints (score 1) 1-3 small joints (with or without involvement of large joints)#(score2) 4-10 small joints (with or without involvement of large joints)(score 3) 10 joints (at least 1 small joint) (score 5)

B.Serology (at least 1 test result is needed for classification)

时间窗: 1 day

Negative RF and negative ACPA (Score 0) Low-positive RF or low-positive ACPA( anticitrullinated protein antibody) (score 2) High-positive RF(rheumatoid factor) or high-positive ACPA (score 3)

D.Duration of symptoms

时间窗: 1 day

\<6 weeks (score 0) \>6 weeks (score 1)

Uromodulin measure

时间窗: 1 day

First urine sample taken in the morning

次要结局

  • pH measure(1 day)
  • Microalbuminuria measure(1 day)
  • MDRD (Modification of Diet in Renal Disease)(1 day)
  • Sedimantation measure(1 day)
  • Urea measure(1 day)
  • CKD-EPI (Chronic Kidney Disease Epidemiology Colloboration)(1 day)
  • Creatinine measure(1 day)

研究者

发起方
neval aksoy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

neval aksoy

Medical Doctor, Head of Urine Laboratory Department

Istanbul Saglik Bilimleri University

研究点 (1)

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