NCT Number: NCT03358966
Energy Expenditure in Chronic Kidney Disease
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- CKD stages 1-5 according to the MDRD equation eGFR
- Age >18
Exclusion criteria
- Abnormal thyroid stimulating hormone level or previous thyroid disorder
- Active malignancy
- Pregnancy
- 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).
Treatment and study plan
Resting Energy Expenditure
OtherResting energy expenditure represents the amount of calories required for a 24-hour period by the body during a non-active period.
Primary outcomes
-
Energy expenditure using doubly labelled water
Time frame: 14 days
Secondary outcomes
-
Whole body bioimpedance
Time frame: 1 day
-
Resting Energy Expenditure using indirect calorimetry
Time frame: 1 day
-
Stanford 7 day recall questionnaire physical activity level
Time frame: 7 days
Sponsors and collaborators
Lead sponsor
East and North Hertfordshire NHS Trust
Other Gov
Collaborators
- University of Hertfordshire
Registry information
Official study title
Energy Expenditure in Chronic Kidney Disease: a Doubly Labelled Water Study
Important dates
- Study start
- 2008
- Primary completion
- 2014
- Study completion
- 2015
- First posted
- Dec 2, 2017
- Registry last updated
- Dec 4, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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