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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03972098
Uromodulin in Rheumatoid Arthritis
Uromodulin Levels in Rheumatoid Arthritis
Visão geral do estudo
Status
Condições
Descrição detalhada
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 de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Istanbul, Peru
- Istanbul saglık Bilimleri Universty Gaziosmanpaşa Egitim ve Araştırma Hastanesi
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Patients with rheumatoid arthritis
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 1 day
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First urine sample taken in the morning
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1 day
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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CKD-EPI (Chronic Kidney Disease Epidemiology Colloboration)
Prazo: 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)
Prazo: 1 day
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For estimating the glomerular filtration rate
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1 day
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Urea measure
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 1 day
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First urine sample taken in the morning
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1 day
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: neval aksoy, MD, Sağlık Bilimleri Universty
- Investigador principal: lüfiye aytüre, MD, Sağlık Bilimleri Universty
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Gaziosmanpasa Hospital
Plano para dados de participantes individuais (IPD)
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