Energy Expenditure in Chronic Kidney Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Diseases; Chronic Kidney Diseases
• Intervention / Treatment: Other: Doubly-labelled water technique; Other: Resting Energy Expenditure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease who attended the renal clinics of the East and North Herts NHS Trust

Description

Inclusion Criteria:

1. CKD stages 1-5 according to the MDRD equation eGFR
2. Age >18

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early to moderate CKD (stage 1-3); 40 patients with CKD stage 1-3. All subjects performed a comprehensive metabolic analysis including measurement of Resting Energy Expenditure using indirect calorimetry, bioimpedance, doubly-labelled water technique and body size measures. Physical activity was assessed using a Stanford 7 day recall questionnaire.	Other: Doubly-labelled water technique; Other: Resting Energy Expenditure; Resting energy expenditure represents the amount of calories required for a 24-hour period by the body during a non-active period.
Advanced CKD (stage 4-5); 40 patients with CKD stage 4-5. All subjects performed a comprehensive metabolic analysis including measurement of Resting Energy Expenditure using indirect calorimetry, bioimpedance, doubly-labelled water technique and body size measures. Physical activity was assessed using a Stanford 7 day recall questionnaire.	Other: Doubly-labelled water technique; Other: Resting Energy Expenditure; Resting energy expenditure represents the amount of calories required for a 24-hour period by the body during a non-active period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Energy expenditure using doubly labelled water	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Whole body bioimpedance	1 day
Resting Energy Expenditure using indirect calorimetry	1 day
Stanford 7 day recall questionnaire physical activity level	7 days

Collaborators and Investigators

• Sponsor: East and North Hertfordshire NHS Trust
• Collaborators: University of Hertfordshire
• Investigators: Study Chair: Professor Ken Farrington, East and North Hertfordshire NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2008
• Primary Completion (Actual): May 30, 2014
• Study Completion (Actual): May 30, 2015

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: chronic kidney disease; energy expenditure; metabolic rate
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 08/H/0311/103 (REC No.); RP27/2010 (Other Grant/Funding Number: Kidney Research UK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No