Novel Equations for Estimating Lean Body Mass in Patients With Chronic Kidney Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Lean Body Mass

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Renal Division and Institute of Nephrology, Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The development and validation groups both included 150 non-dialyzed patients with CKD stage 3-5.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LBM_DEXA	lean body mass measured by dual-energy x-ray absorptiometry (DEXA)	between March 1st, 2014 and December 1st, 2015

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 7, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: dual-energy x-ray absorptiometry; handgrip strength; mid-arm muscle circumference
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: LBM eqations

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No