Clinical trial NCT03972098: Uromodulin in Rheumatoid Arthritis
Official title: Uromodulin Levels in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: uromodulin
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

In order to eliminate the possibility of any systemic disease therefore we choose that our control group as young

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.

Eligibility criteria: Inclusion Criteria:

* Patients who diagnosed of rheumatoid arthritis as criteria of ACR/EULAR 2010.
* 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

Primary outcomes:
measure: Patients with rheumatoid arthritis
timeFrame: 1 day
measure: A.joint involvement
timeFrame: 1 day
measure: B.Serology (at least 1 test result is needed for classification)
timeFrame: 1 day
measure: C.Acute-phase reactants (at least 1 test result is needed for classification)
timeFrame: 1 day
measure: D.Duration of symptoms
timeFrame: 1 day
measure: Uromodulin measure
timeFrame: 1 day
Secondary outcomes:
measure: CKD-EPI (Chronic Kidney Disease Epidemiology Colloboration)
timeFrame: 1 day
measure: MDRD (Modification of Diet in Renal Disease)
timeFrame: 1 day
measure: Urea measure
timeFrame: 1 day
measure: Creatinine measure
timeFrame: 1 day
measure: Sedimantation measure
timeFrame: 1 day
measure: pH measure
timeFrame: 1 day
measure: Microalbuminuria measure
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul saglık Bilimleri Universty Gaziosmanpaşa Egitim ve Araştırma Hastanesi
Study officials:
affiliation: Sağlık Bilimleri Universty
name: neval aksoy, MD
role: STUDY_CHAIR
affiliation: sağlık Bilimleri Universty
name: lüfiye aytüre, MD
role: PRINCIPAL_INVESTIGATOR
References: