- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02580266
Blood/Urine Markers for Drug Discovery for Renal Disease in Diabetes (DDRD)
Diabetic nephropathy (kidney problems caused by diabetes) is a devastating chronic vascular complication of diabetes. New treatments are urgently needed for preventing or slowing down the progression of diabetic kidney disease. Samples of serum/plasma/urine will be obtained from patients with diabetes and different degree of renal impairment.
In this project cells in culture will be treated with plasma or serum or urine; cells extracts or supernatant will be studied to screen for modulation (activation/inhibition) of different cellular pathways using gene array, metabolomic and/or proteomic. Once some cellular pathways have been identified specific analysis will be conducted on the biological material collected to confirm specific "cell signatures" that could represent potential target for treatment.
연구 개요
상태
정황
상세 설명
The aim of the study is to investigate novel putative mechanisms involved in the pathophysiology of kidney disease in diabetic patients.
The investigators will make use of plasma, serum or urine obtained from patients with diabetes.
Cells in culture will be treated with plasma or serum or urine; cells extracts or supernatant will be studied to screen for modulation (activation/inhibition) of different cellular pathways using gene array, metabolomic and/or proteomic. Once some cellular pathways have been identified specific analysis will be conducted on the biological material collected to confirm specific "cell signatures" that could represent potential target for treatment.
The investigators will recruit patients with both type 1 and type 2 diabetes attending our outpatient diabetes clinic at Guys' and St Thomas Hospital. The participant will be informed of the aim of the research and if agreeable in donating blood and urine sample; participants will be asked to sign a written informed consent explaining in simple word the aim of the research, the involvement they should have (blood sample and urine sample collection), the minimal risk to which they will be exposed (venopuncture).
The study will involve one or more blood collections from the arm, for up to 30 mls (6 tea spoons) per year (up to 10 yeas duration), to be collected on up to 2 occasions/ year (minimum time between two collections: 4 weeks), with up to 15ml (3 tea spoon) of blood maximum volume taken per occasion. Urine samples (any amount) might also be collected at any time. Blood and urine collections will take approximately 15 minutes.
This research is low risk. Samples will be stored within the Unit of Metabolic Medicine (Dr Gnudi), King's College London, United Kingdom, and its potential future use will be within the remit of the advancement of science and for the benefit of public domain within academic and/or commercial organisations (e.g. pharmaceutical industry) worldwide.
Any information collected from participants during the course of the research will be kept strictly confidential. Any information leaving the hospital will have the name and address of patient removed so that it can not be recognised by third parties.
The results obtained from this research will likely to be published in a medical journal. The investigators will provide copy of any published results to anybody that may request for it. Participants will not be identified in any report/publication.
연구 유형
연락처 및 위치
연구 장소
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London, 영국, SE1 9RT
- Unit for Metabolic Medicine, King's College London
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- type 1 and type 2 diabetes
Exclusion Criteria:
- major acute cardio (myocardial infarct, stroke, ec) renal (acute renal failure) events, or severe debilitating disease (e.g. cancer) during the 6 months before the blood/urine collection.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Cellular phenotype
기간: 5 years
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Cellular phenotype (gene and protein expression level)
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5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Luigi Gnudi, MD, PhD, King's College London
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .