Resting Energy ExpenditureNCT03377413
Novel Equation for Estimating Resting Energy Expenditure
An observational study of Resting Energy Expenditure and Chronic Kidney Disease, run by Peking University First Hospital at 1 site in China.
Trial summary
The energy and nutrition states are closely associated with CKD patients complications and outcomes.To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Resting Energy Expenditure, Chronic Kidney Disease
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 14 Dec 2017to 1 Feb 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic kidney disease 3-5 stages
Who may be able to join
- CKD 3-5 stages
- Age:18-80 years old
Who cannot join
- Dialysis and kidney transplantation;
- Acute complications to hospitalization
- 1 month prior to the study;
- Acute or chronic infections, cancer and other wasting diseases in the past year;
- Thyroid dysfunction;
- Acute onset of podagra; Musculoskeletal diseases;
Show all 9Show fewer
- Respiratory diseases (asthma, pleural effusion, pneumothorax, COPD);
- History of hormonal drugs use;
- During pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site
Renal Division and Institute of Nephrology, Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
Official title: Novel Equation for Estimating Resting Energy(REE) Expenditure in Chronic Kidney Disease(CKD) 3-5 Stages Patients
The energy and nutrition states are closely associated with CKD patients complications and outcomes.To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations are not applicable to CKD patients,so we aim to develop and validate a equation for estimating resting energy expenditure in CKD patients.
- Conditions
- Resting Energy Expenditure, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel equation development
Developed equation for estimating REE in CKD 3-5 stages patients
Measured: September 1, 2017 to June 1, 2018
Novel equation validation
Validate the noval equation with REE obtained by indirect calorimetry (IC).
Measured: June 1, 2018 to March 1, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start14 Dec 2017
- Primary completion31 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resting Energy ExpenditureStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jie, Peking University First Hospital
- Investigators
- Jie Dong, Study director, Renal Division and Institute of Nephrology, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377413
- Sponsor's protocol ID
- REE equation
- Status last verified
- Oct 2020
- First submitted
- 14 Dec 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu X, Yang Z, Ma T, Li Z, Chen Y, Zheng Y, Dong J. Novel equation for estimating resting energy expenditure in patients with chronic kidney disease. Am J Clin Nutr. 2021 Jun 1;113(6):1647-1656. doi: 10.1093/ajcn/nqaa431.
PubMed 33693520
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Equation for Estimating Resting Energy(REE) Expenditure in Chronic Kidney Disease(CKD) 3-5 Stages Patients
- ClinicalTrials.gov ID
- NCT03377413
- Acronym / sponsor ID
- REE equation
- Conditions
- Resting Energy Expenditure, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 19 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.
The energy and nutrition states are closely associated with CKD patients complications and outcomes.To reach the energy balance target, we need the accurate resting energy expenditure level of patients. Traditional equations are not applicable to CKD patients,so we aim to develop and validate a equation for estimating resting energy expenditure in CKD patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic kidney disease 3-5 stages
Key inclusion criteria (2 listed)
- CKD 3-5 stages
- Age:18-80 years old
Key exclusion criteria (9 listed)
- Dialysis and kidney transplantation;
- Acute complications to hospitalization
- 1 month prior to the study;
- Acute or chronic infections, cancer and other wasting diseases in the past year;
- Thyroid dysfunction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Novel equation development
Time frame: September 1, 2017 to June 1, 2018
Developed equation for estimating REE in CKD 3-5 stages patients
Novel equation validation
Time frame: June 1, 2018 to March 1, 2019
Validate the noval equation with REE obtained by indirect calorimetry (IC).
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 14 Oct 2020.
- Derived from this study: PubMed 33693520Xu X, Yang Z, Ma T, Li Z, Chen Y, Zheng Y, Dong J. Novel equation for estimating resting energy expenditure in patients with chronic kidney disease. Am J Clin Nutr. 2021 Jun 1;113(6):1647-1656. doi: 10.1093/ajcn/nqaa431.
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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.
Jie Dong study director
Renal Division and Institute of Nephrology, Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resting Energy Expenditure and Chronic Kidney Disease, run by Peking University First Hospital at 1 site in China.
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 9 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Novel equation development (time frame: September 1, 2017 to June 1, 2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377413, which also lists 1 linked publication.
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 14 Oct 2020.