NCT04074278

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

August 28, 2019

Last Update Submit

September 7, 2019

Conditions

Keywords

mid-arm muscle circumferencehandgrip strengthdual-energy x-ray absorptiometry

Outcome Measures

Primary Outcomes (1)

  • LBM_DEXA

    lean body mass measured by dual-energy x-ray absorptiometry (DEXA)

    between March 1st, 2014 and December 1st, 2015

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • non-dialyzed patients with CKD stage 3-5
  • clinical stable
  • a willingness to be examined with all measurements being taken simultaneously.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renal Division and Institute of Nephrology, Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Institute of Nephrology, Division of Renal

Study Record Dates

First Submitted

August 28, 2019

First Posted

August 30, 2019

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 10, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations