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临床试验/NCT03358966
NCT03358966已完成不适用

Energy Expenditure in Chronic Kidney Disease: a Doubly Labelled Water Study

East and North Hertfordshire NHS Trust0 个研究点目标入组 80 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
主要终点
Energy expenditure using doubly labelled water

研究概览

简要总结

Patients with kidney disease need accurate advice on their diet. Researchers know very little about energy needs and nutritional requirements in kidney patients. Simple tools are needed to calculate calorie requirements so that good bed-side advice can be given to patients, and to allow cost-effective research. This study aimed to measur energy requirements in kidney disease using a gold-standard safe and very accurate method called the "doubly labelled water technique". The study has compared measurements with less costly measurements obtained using a device which measures oxygen content of air breathed out. The study has also measured physical activity levels with questionnaires.

详细描述

Background The function of the kidneys is to remove waste products of metabolism, and despite advances in treatment of CKD little is known about metabolic rate in renal disease. Increased knowledge about metabolic rate would have numerous potential benefits.

Little is known of the effects of metabolic rate on kidney disease. This study was designed to define the relationship of metabolic rate with degree of kidney function.

Study design and methods In an observational cohort study, the investigators studied Total Energy Expenditure in 80 patients with CKD stage 1-5 using the doubly-labelled water technique over a 14 day period. The group was divided such that half had stage 1-3 CKD and half stage 4-5. All subjects performed a comprehensive metabolic analysis including measurement of Resting Energy Expenditure using indirect calorimetry, bioimpedance, and body size measures. Physical activity was assessed using a Stanford 7 day recall questionnaire.

Data Analysis The data analysed will include determining the relationship between level of kidney disease as measured by eGFR and energy expenditure measured as Resting Energy Expenditure and doubly-labelled water Total Energy Expenditure. This will be determined by regression analysis. Additionally, comparison will be made between subjects with early-moderate (CKD stage 1-3) and advanced (CKD stage 4-5) CKD.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CKD stages 1-5 according to the MDRD equation eGFR

排除标准

  • Abnormal thyroid stimulating hormone level or previous thyroid disorder
  • Active malignancy
  • Intercurrent illness or infection
  • Hospital admission in month prior to enrolment
  • Surgery in 4 weeks prior to enrolment
  • HIV, Hepatitis B, Hepatitis C positive status
  • Tuberculosis in the 12 months prior to enrolment.
  • Active vasculitis or connective tissue disorder
  • Organ transplantation.
  • Treatment with immunosuppression, except low dose corticosteroids (<10mg/day prednisolone).

结局指标

主要结局

Energy expenditure using doubly labelled water

时间窗: 14 days

次要结局

  • Resting Energy Expenditure using indirect calorimetry(1 day)
  • Whole body bioimpedance(1 day)
  • Stanford 7 day recall questionnaire physical activity level(7 days)

研究者

发起方
East and North Hertfordshire NHS Trust
申办方类型
Other Gov
责任方
Sponsor

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