- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03972098
Uromodulin in Rheumatoid Arthritis
Uromodulin Levels in Rheumatoid Arthritis
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Istanbul, 칠면조
- Istanbul saglık Bilimleri Universty Gaziosmanpaşa Egitim ve Araştırma Hastanesi
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patients with rheumatoid arthritis
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 1 day
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First urine sample taken in the morning
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1 day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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CKD-EPI (Chronic Kidney Disease Epidemiology Colloboration)
기간: 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)
기간: 1 day
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For estimating the glomerular filtration rate
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1 day
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Urea measure
기간: 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
기간: 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
기간: 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
기간: 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
기간: 1 day
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First urine sample taken in the morning
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1 day
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: neval aksoy, MD, Sağlık Bilimleri Universty
- 수석 연구원: lüfiye aytüre, MD, Sağlık Bilimleri Universty
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .