NCT02277236

Brief Summary

This pilot study will aid the development of a sonographic screening method used to obtain proxy measures of LBM and estimates of muscle composition that relate to Intramuscular adipose tissue (IMAT), lipid metabolism, and insulin resistance. Typically, age-related muscle loss is not assessed in older adults until they began to show signs of trouble managing their own lives independently. In addition to the loss of independence that is typically seen with diminished muscle mass and function (sarcopenia), age-related changes in lean body mass can have negative effects on insulin sensitivity. The investigators central hypothesis is that the muscle characteristics derived from ultrasound (US) will be significantly associated with estimates of dual energy X-ray absorptiometry (DXA) LBM, CT scan measures of IMAT, estimates of insulin homeostasis, and serum levels of inflammatory cytokines.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

October 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

2.9 years

First QC Date

October 18, 2014

Last Update Submit

December 18, 2019

Conditions

Sarcopenia

Keywords

sarcopeniaaginginsulin resistancescreening

Outcome Measures

Primary Outcomes (1)

  • Sonographic Lean Body Mass

    US estimates of aggregate regional LBM (muscle thickness, cm), will be assessed using B-mode diagnostic US with a 13-6 MHz linear array transducer for morphology measures at 6 axial and appendicular sites. The following sites will be assessed: the midpoint of the upper trapezius, upper pectoralis major, lateral deltoid, brachioradialis, rectus femoris, and tibialis anterior.

    1 day

Secondary Outcomes (6)

  • Metabolic status

    1 day

  • DXA lean body mass

    At time of assessment

  • Intramuscular adipose tissue assessment

    1 day

  • Strength assessment

    1 day

  • Functional assessment

    1 day

  • +1 more secondary outcomes

Study Arms (2)

Younger Veterans

Male Veterans, 45-64.9 years of age. (Exposures include DXA scanning and CT imaging.)

Radiation: DXA scanningRadiation: CT imaging

Young-Old Veterans

Male Veterans, 65-84.9 years of age. (Exposures include DXA scanning and CT imaging.)

Radiation: DXA scanningRadiation: CT imaging

Interventions

DXA scanningRADIATION

Exposure: Participants will undergo DXA scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total lean body mass (LBM) and body fat (BF).

Also known as: Radiograph, x-rays
Young-Old VeteransYounger Veterans
CT imagingRADIATION

Exposure: Estimates of intramuscular adipose tissue (IMAT) will be obtained with CT imaging. This measure will be restricted to a single leg (dominant side) in the mid-femur region, using a single 10mm axial image slice (120 kVp, 200 to 250 mA).

Also known as: CAT scan
Young-Old VeteransYounger Veterans

Eligibility Criteria

Age45 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veteran men (45-85 years of age; n = 30) consecutively recruited from outpatients at the DC VAMC and assigned to a "younger" or "young old" group (i.e., 45-64.9, and 65-84.9 years of age).

You may qualify if:

  • You are registered to receive healthcare at the Washington DC VAMC through the Geriatrics Extended Care Service and/or Primary Care Service.
  • You are a male.
  • You are between the ages of 45 - 85 years.
  • Must be able to stand comfortably for 10 minutes and walk a short distance (use of assistive devices are acceptable).

You may not qualify if:

  • You have uncontrolled hypertension.
  • Body Mass Index (BMI) \<18.5 or \>32.5.
  • Musculoskeletal conditions that would stop you from performing the physical assessment test.
  • Muscle weakness due to neurological disease or injury (such as stroke or spinal cord injury).
  • Moderate to severe sepsis (blood infection) or edema (such as swelling of a limb).
  • Currently prescribed medications that affect glucose or insulin.
  • Uncontrolled cardiovascular disease.
  • Hospitalization over the last three months.
  • Diagnosis of diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington DC VA Medical Center

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

Location

Related Publications (3)

  • Harris-Love MO, Adams B, Hernandez HJ, DiPietro L, Blackman MR. Disparities in the consequences of sarcopenia: implications for African American Veterans. Front Physiol. 2014 Jul 7;5:250. doi: 10.3389/fphys.2014.00250. eCollection 2014. No abstract available.

    PMID: 25071595BACKGROUND

  • Harris-Love MO, Monfaredi R, Ismail C, Blackman MR, Cleary K. Quantitative ultrasound: measurement considerations for the assessment of muscular dystrophy and sarcopenia. Front Aging Neurosci. 2014 Jul 14;6:172. doi: 10.3389/fnagi.2014.00172. eCollection 2014. No abstract available.

    PMID: 25071570BACKGROUND

  • 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected for determination of lipid profiles, fasting insulin and glucose levels, the oral glucose tolerance test, and selected cytokines (IL-6 and TNF-α).

MeSH Terms

Conditions

SarcopeniaInsulin Resistance

Interventions

X-RaysPostmortem Imaging

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, IonizingAutopsyDiagnostic Techniques and ProceduresDiagnosisDiagnostic ImagingInvestigative Techniques

Study Officials

  • Michael Harris-Love, MPT, DSc

    Washington DC VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2014

First Posted

October 28, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2017

Study Completion

August 1, 2020

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations

US(1)