- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03972098
Uromodulin in Rheumatoid Arthritis
Uromodulin Levels in Rheumatoid Arthritis
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Istanbul, Tacchino
- Istanbul saglık Bilimleri Universty Gaziosmanpaşa Egitim ve Araştırma Hastanesi
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Patients with rheumatoid arthritis
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 day
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First urine sample taken in the morning
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1 day
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
CKD-EPI (Chronic Kidney Disease Epidemiology Colloboration)
Lasso di tempo: 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)
Lasso di tempo: 1 day
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For estimating the glomerular filtration rate
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1 day
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Urea measure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 1 day
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First urine sample taken in the morning
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1 day
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: neval aksoy, MD, Sağlık Bilimleri Universty
- Investigatore principale: lüfiye aytüre, MD, Sağlık Bilimleri Universty
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Gaziosmanpasa Hospital
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