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Energy Expenditure in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03358966
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : December 4, 2017
Sponsor:
Collaborator:
University of Hertfordshire
Information provided by (Responsible Party):
East and North Hertfordshire NHS Trust

Brief Summary:
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.

Condition or disease Intervention/treatment
Kidney Diseases Chronic Kidney Diseases 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.


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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Energy Expenditure in Chronic Kidney Disease: a Doubly Labelled Water Study
Actual Study Start Date : September 1, 2008
Actual Primary Completion Date : May 30, 2014
Actual Study Completion Date : May 30, 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Energy expenditure using doubly labelled water [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Whole body bioimpedance [ Time Frame: 1 day ]
  2. Resting Energy Expenditure using indirect calorimetry [ Time Frame: 1 day ]
  3. Stanford 7 day recall questionnaire physical activity level [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358966


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

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Responsible Party: East and North Hertfordshire NHS Trust
ClinicalTrials.gov Identifier: NCT03358966     History of Changes
Other Study ID Numbers: 08/H/0311/103 (REC No.)
RP27/2010 ( Other Grant/Funding Number: Kidney Research UK )
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by East and North Hertfordshire NHS Trust:
chronic kidney disease
energy expenditure
metabolic rate

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency