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- Essai clinique NCT03972098
Uromodulin in Rheumatoid Arthritis
Uromodulin Levels in Rheumatoid Arthritis
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Istanbul, Turquie
- Istanbul saglık Bilimleri Universty Gaziosmanpaşa Egitim ve Araştırma Hastanesi
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patients with rheumatoid arthritis
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 1 day
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First urine sample taken in the morning
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1 day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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CKD-EPI (Chronic Kidney Disease Epidemiology Colloboration)
Délai: 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)
Délai: 1 day
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For estimating the glomerular filtration rate
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1 day
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Urea measure
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 1 day
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First urine sample taken in the morning
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1 day
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: neval aksoy, MD, Sağlık Bilimleri Universty
- Chercheur principal: lüfiye aytüre, MD, Sağlık Bilimleri Universty
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Gaziosmanpasa Hospital
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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