- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03972098
Uromodulin in Rheumatoid Arthritis
Uromodulin Levels in Rheumatoid Arthritis
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Istanbul, Kalkon
- Istanbul saglık Bilimleri Universty Gaziosmanpaşa Egitim ve Araştırma Hastanesi
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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.
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healthy control
healthy person, similar population
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Patients with rheumatoid arthritis
Tidsram: 1 day
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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
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1 day
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A.joint involvement
Tidsram: 1 day
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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)
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1 day
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B.Serology (at least 1 test result is needed for classification)
Tidsram: 1 day
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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)
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1 day
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C.Acute-phase reactants (at least 1 test result is needed for classification)
Tidsram: 1 day
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Normal CRP (C-reactive protein and normal) and normal ESR (erythrocyte sedimentation rate) (score 0) Abnormal CRP or abnormal ESR (score1)
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1 day
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D.Duration of symptoms
Tidsram: 1 day
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<6 weeks (score 0) >6 weeks (score 1)
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1 day
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Uromodulin measure
Tidsram: 1 day
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First urine sample taken in the morning
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1 day
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
CKD-EPI (Chronic Kidney Disease Epidemiology Colloboration)
Tidsram: 1 day
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For estimating the glomerular filtration rate
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1 day
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MDRD (Modification of Diet in Renal Disease)
Tidsram: 1 day
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For estimating the glomerular filtration rate
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1 day
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Urea measure
Tidsram: 1 day
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Fasting blood samples taken in the morning
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1 day
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Creatinine measure
Tidsram: 1 day
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Fasting blood samples taken in the morning
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1 day
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Sedimantation measure
Tidsram: 1 day
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Fasting blood samples taken in the morning
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1 day
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pH measure
Tidsram: 1 day
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First urine sample taken in the morning
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1 day
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Microalbuminuria measure
Tidsram: 1 day
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First urine sample taken in the morning
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1 day
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: neval aksoy, MD, Sağlık Bilimleri Universty
- Huvudutredare: lüfiye aytüre, MD, Sağlık Bilimleri Universty
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Gaziosmanpasa Hospital
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