NCT03160326

Brief Summary

Currently there is no standard way to detect age-related skeletal muscle loss in patients with chronic kidney disease. Investigators are working on finding rapid and inexpensive ways to measure muscle size and fat within the muscle.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

3.1 years

First QC Date

October 5, 2016

Last Update Submit

November 8, 2018

Conditions

Chronic Kidney DiseaseSarcopenia

Keywords

chronic kidney diseaseultrasoundmuscle loss

Outcome Measures

Primary Outcomes (5)

  • Muscle Quality

    Muscle measurements at 6 sites using diagnostic ultrasound (grayscale levels, 0-255)

    day 1

  • Lean Body Mass

    Dual Energy X-ray Absorptiometry (DXA) scan (kg/m2)

    day 1

  • Grip Strength

    Measured using a dynamometer (kg)

    day 1

  • Short Physical Performance Battery

    Performance-based functional assessment battery; scores range from 0 (worst performance) to 12 (best performance)

    day 1

  • Timed Up-and-Go

    Performance-based fall risk assessment

    day 1

Secondary Outcomes (11)

  • Height

    day 1

  • Weight

    day 1

  • Hip/waist circumference

    day 1

  • Body composition

    day 1

  • Isometric peak knee extension force

    day 1

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participating Veterans in this study will undergo their standard examination by the DC or SF VA Medical Center Renal Service staff physicians and will be formally staged for CKD. Fifty adult patients with Stage 3 or 4 CKD (i.e., a definitive CKD diagnosis, but prior to the need for dialysis) will be enrolled following consent and then scheduled for the study assessments at their local study center.

You may qualify if:

  • Ambulatory patients (with or without a gait aid)
  • years of age with CKD stage 3 or 4
  • Receiving care at the DC or SF VA Medical Center Renal Service
  • Able to speak and read English
  • Orientation to person, place, and time

You may not qualify if:

  • Acute renal failure
  • Pregnancy
  • Any uncontrolled cardiovascular or musculoskeletal disease that, in the opinion of the principal investigator, could make participation unsafe
  • Body size exceeds the dimensional limits of the DXA scanner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

RECRUITING

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

RECRUITING

Related Publications (1)

  • Gollie JM, Harris-Love MO, Patel SS, Shara NM, Blackman MR. Rate of Force Development Is Related to Maximal Force and Sit-to-Stand Performance in Men With Stages 3b and 4 Chronic Kidney Disease. Front Rehabil Sci. 2021 Sep 28;2:734705. doi: 10.3389/fresc.2021.734705.

    PMID: 34708217DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicSarcopeniaMuscular Atrophy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Cynthia Delgado, MD

    San Francisco VA Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Delgado, MD

CONTACT

415-221-4810Cynthia.Delgado@ucsf.edu

Michael Harris-Love, DSc

CONTACT

202-745-8000Michael.Harris-Love@va.gov

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2016

First Posted

May 19, 2017

Study Start

September 1, 2016

Primary Completion

October 1, 2019

Study Completion

March 1, 2020

Last Updated

November 9, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

Data will be shared between the two study sites: the Washington DC and San Francisco VA Medical Centers

Locations

US(2)