Kidney DiseasesNCT03358966
Energy Expenditure in Chronic Kidney Disease
An observational study of Kidney Diseases and Chronic Kidney Diseases, run by East and North Hertfordshire NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Chronic Kidney Diseases
- What is being tested?
- Doubly-labelled water technique and Resting Energy Expenditure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2008to 30 May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic kidney disease who attended the renal clinics of the East and North Herts NHS Trust
Who may be able to join
- CKD stages 1-5 according to the MDRD equation eGFR
- Age >18
Who cannot join
- 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
Show all 11Show fewer
- 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).
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Diseases, Chronic Kidney Diseases
- Being tested
- Doubly-labelled water technique, Resting Energy Expenditure
- Keywords
- chronic kidney disease, energy expenditure, metabolic rate
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doubly-labelled water techniqueOther
Resting Energy ExpenditureOther
Resting energy expenditure represents the amount of calories required for a 24-hour period by the body during a non-active period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Doubly-labelled water technique; Other: Resting Energy Expenditure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure using doubly labelled water
Measured: 14 days
Secondary outcomes (3)
Whole body bioimpedance
Measured: 1 day
Resting Energy Expenditure using indirect calorimetry
Measured: 1 day
Stanford 7 day recall questionnaire physical activity level
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Sep 2008
- Primary completion30 May 2014
- Study completion30 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hertfordshire
- Responsible party
- Sponsor
- Investigators
- Professor Ken Farrington, Study chair, East and North Hertfordshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358966
- Sponsor's protocol ID
- 08/H/0311/103 (REC No.)
- Other IDs
- RP27/2010
- Status last verified
- Oct 2017
- First submitted
- 27 Nov 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Expenditure in Chronic Kidney Disease: a Doubly Labelled Water Study
- ClinicalTrials.gov ID
- NCT03358966
- Acronym / sponsor ID
- 08/H/0311/103 (REC No.)
- Conditions
- Kidney Diseases, Chronic Kidney Diseases
- Keywords
- chronic kidney disease, energy expenditure, metabolic rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- University of Hertfordshire
- Study start
- 1 Sep 2008 (actual)
- Primary completion
- 30 May 2014 (actual)
- Study completion
- 30 May 2015 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early to moderate CKD (stage 1-3) | – | Other: Doubly-labelled water technique, Other: Resting Energy Expenditure40 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. |
| Advanced CKD (stage 4-5) | – | Other: Doubly-labelled water technique, Other: Resting Energy Expenditure40 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease who attended the renal clinics of the East and North Herts NHS Trust
Key inclusion criteria (2 listed)
- CKD stages 1-5 according to the MDRD equation eGFR
- Age >18
Key exclusion criteria (11 listed)
- Abnormal thyroid stimulating hormone level or previous thyroid disorder
- Active malignancy
- Pregnancy
- Intercurrent illness or infection
- Hospital admission in month prior to enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doubly-labelled water technique | Other | Advanced CKD (stage 4-5), Early to moderate CKD (stage 1-3) |
| Resting Energy ExpenditureResting energy expenditure represents the amount of calories required for a 24-hour period by the body during a non-active period. | Other | Advanced CKD (stage 4-5), Early to moderate CKD (stage 1-3) |
Primary outcome
Energy expenditure using doubly labelled water
Time frame: 14 days
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Ken Farrington study chair
East and North Hertfordshire NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases and Chronic Kidney Diseases, run by East and North Hertfordshire NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure using doubly labelled water (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.