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Clinical Trials/NCT03972098
NCT03972098CompletedNot Applicable

Uromodulin Levels in Rheumatoid Arthritis

neval aksoy1 site in 1 country86 target enrollmentStarted: May 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
86
Locations
1
Primary Endpoint
C.Acute-phase reactants (at least 1 test result is needed for classification)

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • Not provided

Arms & Interventions

healthy control

healthy person, similar population

Intervention: healthy control

ra patients

The diagnosis of RA was based on the criteria developed by the American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) in 2010 [8]. A drug history was obtained from every patient. All non-steroidal anti-inflammatory medications and disease-modifying antirheumatic drugs prescribed during the year before enrollment in the study were recorded. criteria included systemic diseases (renal failure, hepatic insufficiency, diabetes mellitus, other collagen vascular diseases, history of smoking and consumption of alcohol.In order to eliminate the possibility of any systemic disease therefore we choose that our control group as young.

Intervention: ra patients

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 1 day

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

Uromodulin measure

Time Frame: 1 day

First urine sample taken in the morning

Secondary Outcomes

  • 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)
  • pH measure(1 day)
  • Microalbuminuria measure(1 day)

Investigators

Sponsor
neval aksoy
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

neval aksoy

Medical Doctor, Head of Urine Laboratory Department

Istanbul Saglik Bilimleri University

Study Sites (1)

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