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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04074278
Other study ID # LBM eqations
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2013
Est. completion date December 1, 2015

Study information

Verified date September 2019
Source Peking University First Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 1, 2015
Est. primary completion date December 1, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- non-dialyzed patients with CKD stage 3-5

- clinical stable

- a willingness to be examined with all measurements being taken simultaneously.

Exclusion Criteria:

- 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

Study Design


Locations

Country Name City State
China Renal Division and Institute of Nephrology, Peking University First Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary LBM_DEXA lean body mass measured by dual-energy x-ray absorptiometry (DEXA) between March 1st, 2014 and December 1st, 2015
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