Energy Expenditure in Chronic Kidney Disease

NCT03358966 | Completed

• 2 other identifiers: 08/H/0311/103 (REC No.)RP27/2010
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Diseases; Chronic Kidney Diseases

Keywords

chronic kidney disease; energy expenditure; metabolic rate

Outcome Measures

Primary Outcomes (1)

• Energy expenditure using doubly labelled water

  14 days

Secondary Outcomes (3)

• Whole body bioimpedance

  1 day

• Resting Energy Expenditure using indirect calorimetry

  1 day

• Stanford 7 day recall questionnaire physical activity level

  7 days

Study Arms (2)

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

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

Interventions

Doubly-labelled water technique OTHER

Advanced CKD (stage 4-5); Early to moderate CKD (stage 1-3)

Resting Energy Expenditure OTHER

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); Early to moderate CKD (stage 1-3)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• CKD stages 1-5 according to the MDRD equation eGFR
• Age \>18

You may not qualify if:

• 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).

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead
• University of Hertfordshire: collaborator

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Professor Ken Farrington

  East and North Hertfordshire NHS Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: September 1, 2008
• Primary Completion: May 30, 2014
• Study Completion: May 30, 2015
• Last Updated: December 4, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share