Lean Body MassNCT04074278
Novel Equations for Estimating Lean Body Mass in Patients With Chronic Kidney Disease
An observational study of Lean Body Mass and Chronic Kidney Diseases, run by Peking University First Hospital at 1 site in China.
Trial summary
Simplified methods to estimate lean body mass (LBM), an important nutritional measure representing muscle mass and somatic protein, are lacking in non-dialyzed patients with chronic kidney disease (CKD). Objective: We developed and tested a reliable equations for estimation of LBM in daily clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lean Body Mass, Chronic Kidney Diseases
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2013to 1 Dec 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The development and validation groups both included 150 non-dialyzed patients with CKD stage 3-5.
Who may be able to join
- non-dialyzed patients with CKD stage 3-5
- clinical stable
- a willingness to be examined with all measurements being taken simultaneously.
Who cannot join
- systemic infections, acute cardiovascular events, operations, trauma, active hepatitis or tumor
- severe edema within one month prior to the study
- chronic infections, connective tissue disease, hyper- or hypothyroidism, amputations or pregnancy,
- taking immunosuppressive agents and anti-inflammatory medication chronically
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
Simplified methods to estimate lean body mass (LBM), an important nutritional measure representing muscle mass and somatic protein, are lacking in non-dialyzed patients with chronic kidney disease (CKD).
Objective: We developed and tested a reliable equations for estimation of LBM in daily clinical practice.
Read the detailed description
Two cross-sectional data sets were derived from outpatients with CKD stage 3-5 in Peking University First Hospital.Two equations for estimating LBM based on midarm muscle circumference (MAMC) or hand grip strength (HGS)were developed and validated in CKD patients with dual-energy x-ray absorptiometry (DEXA) as referenced gold method. Demographic data, comorbidity, and other clinical variables were also recorded.
- Conditions
- Lean Body Mass, Chronic Kidney Diseases
- Keywords
- mid-arm muscle circumference, handgrip strength, dual-energy x-ray absorptiometry
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| development groups | The development groups included 150 patients derived from outpatients in Peking University First Hospital, between March 1st, 2014 and November 26th 2014. | |
| validation groups | The validation groups included 150 patients derived from outpatients in Peking University First Hospital, between November 27th 2014 and December 1st, 2015. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LBM_DEXA
lean body mass measured by dual-energy x-ray absorptiometry (DEXA)
Measured: between March 1st, 2014 and December 1st, 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start1 Mar 2013
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lean Body MassStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04074278
- Sponsor's protocol ID
- LBM eqations
- Status last verified
- Sep 2019
- First submitted
- 28 Aug 2019
- Last updated
- 10 Sep 2019
- 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 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Equations for Estimating Lean Body Mass in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04074278
- Acronym / sponsor ID
- LBM eqations
- Conditions
- Lean Body Mass, Chronic Kidney Diseases
- Keywords
- mid-arm muscle circumference, handgrip strength, dual-energy x-ray absorptiometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 30 Aug 2019 (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.
Simplified methods to estimate lean body mass (LBM), an important nutritional measure representing muscle mass and somatic protein, are lacking in non-dialyzed patients with chronic kidney disease (CKD).
Objective: We developed and tested a reliable equations for estimation of LBM in daily clinical practice.
Detailed description
Two cross-sectional data sets were derived from outpatients with CKD stage 3-5 in Peking University First Hospital.Two equations for estimating LBM based on midarm muscle circumference (MAMC) or hand grip strength (HGS)were developed and validated in CKD patients with dual-energy x-ray absorptiometry (DEXA) as referenced gold method. Demographic data, comorbidity, and other clinical variables were also recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| development groups | – | –The development groups included 150 patients derived from outpatients in Peking University First Hospital, between March 1st, 2014 and November 26th 2014. |
| validation groups | – | –The validation groups included 150 patients derived from outpatients in Peking University First Hospital, between November 27th 2014 and December 1st, 2015. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The development and validation groups both included 150 non-dialyzed patients with CKD stage 3-5.
Key inclusion criteria (3 listed)
- non-dialyzed patients with CKD stage 3-5
- clinical stable
- a willingness to be examined with all measurements being taken simultaneously.
Key exclusion criteria (4 listed)
- systemic infections, acute cardiovascular events, operations, trauma, active hepatitis or tumor
- severe edema within one month prior to the study
- chronic infections, connective tissue disease, hyper- or hypothyroidism, amputations or pregnancy,
- taking immunosuppressive agents and anti-inflammatory medication chronically
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
LBM_DEXA
Time frame: between March 1st, 2014 and December 1st, 2015
lean body mass measured by dual-energy x-ray absorptiometry (DEXA)
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 10 Sep 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lean Body Mass and Chronic Kidney Diseases, 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 3 inclusion and 4 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 10 Sep 2019. 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?
LBM_DEXA (time frame: between March 1st, 2014 and December 1st, 2015). 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 10 Sep 2019.