- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02042768
Observational Study of Glucose Metabolism and How Dialysate Glucose Affects This (PD-CRAFT)
An Investigation of the Effects of Different Dialysis Prescriptions on Systemic Glucose Metabolism and Mortality in Non-diabetic Peritoneal Dialysis Patients
Peritoneal Dialysis (PD) is a commonly used treatment for end stage renal failure, and the most commonly used dialysate contains unphysiological amounts of glucose, a high proportion of which is absorbed. Recent analysis of the Global Fluid Study, has established that in non-diabetic prevalent patients on PD a random glucose level is dependent on dialysate glucose load and is a predictor of death. By utilising clinical data and additional biosamples collected for the NIHR funded PD-CRAFT study, the investigators aim to confirm this finding, define the relationship between dialysate glucose exposure according to prescription regimes and glycaemia, define the most useful biomarker to monitor glycaemia , and establish the role that impaired insulin sensitivity plays in blood glucose levels. Furthermore the investigators will explore the hypothesis that insulin resistance is associated with disturbance of the carnitine/acetyl-carnitine equilibrium that might benefit from intra-peritoneal carnitine supplementation.
PD-CRAFT is an observational cohort study of 3000 prevalent PD patients collecting detailed clinical data, including glucose exposure and samples of dialysate. and blood which will be stored in the UK BioCentre. Follow up is for up to 2 years or endpoint (death, technique failure).
Multivariate regression will be used to establish determinants of the non-fasting blood glucose and other measures of glycaemia, in particular different dialysis regimes, (e.g. modality, dwell lengths, fill volumes, and dialysate type and concentration specifically seeking to identify prescriptions that minimise the systemic effects) combined with measures of insulin resistance. The investigators will establish whether blood glucose predicts survival in an adjusted analysis (~300 endpoints needed) using Cox regression and explore the relationship of other biomarkers to survival.
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
North Staffordshire
-
Stoke-on-Trent, North Staffordshire, 영국, ST4 6QG
- University Hospital of North Staffordshire
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- On peritoneal dialysis
Exclusion Criteria:
- Not providing informed consent.
- Diabetes.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mortality
기간: Patients will be followed up for the duration of the study period, an expected average of 24 months
|
From study entry to date of death from any cause, assessed up to June 2015
|
Patients will be followed up for the duration of the study period, an expected average of 24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cardiovascular mortality
기간: Patients will be followed up for the duration of the study period, an expected average of 24 months
|
From study entry up to date of death from cardiovascular cause, assessed up to June 2015
|
Patients will be followed up for the duration of the study period, an expected average of 24 months
|
공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Mark Lambie, MD, Keele University
간행물 및 유용한 링크
유용한 링크
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 (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. .