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Clinical Trials/NCT02277236
NCT02277236
Unknown
Not Applicable

Creating a Model of Proactive Geriatric Care Within VISN 5: Screening for Age-Related Skeletal Muscle Dysfunction at the Washington DC VA Medical Center

Washington D.C. Veterans Affairs Medical Center1 site in 1 country30 target enrollmentOctober 2014
ConditionsSarcopenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
Washington D.C. Veterans Affairs Medical Center
Enrollment
30
Locations
1
Primary Endpoint
Sonographic Lean Body Mass
Last Updated
6 years ago

Overview

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.

Detailed Description

The primary goals of this project are to: 1) develop and validate a rapid, portable, cost-effective, screening method for sarcopenia using diagnostic ultrasound (US), and 2) determine if the US screening method provides viable estimates of intramuscular adipose tissue (IMAT) since muscle tissue age-related changes in muscle composition are associated with low muscle torque and metabolic dysfunction. The proposed US screening method may be used as a proxy measure of LBM and provide estimates of skeletal muscle composition that relate to IMAT, lipid metabolism, insulin homeostasis and inflammation - important factors that may impact impaired mobility and metabolic dysfunction in older African American Veterans. Aim 1: Determine the association between a proxy measure of LBM obtained via portable, diagnostic, musculoskeletal US and LBM as determined by dual energy X-ray absorptiometry (DXA). The working hypothesis is that a 6-muscle model of LBM derived from US and DXA LBM values will exhibit a significant positive association and attain a coefficient of determination \> .80. Aim 2: Determine the association between US echointensity features and IMAT as determined by CT scan. US echointensity values will be acquired from the rectus femoris and analyzed to determine the association with IMAT. The working hypothesis is that higher echointensity values measured with grayscale analysis will be negatively associated with the Hounsfield units obtained from the CT scan (p \< .05). Aim 3: Examine the association between US echointensity values and biologic factors that impair insulin sensitivity. Excessive IMAT and intra-myocellular triglyceride levels result in increased levels of biologic factors such as inflammatory cytokines (TNF-α and IL-6), which may affect insulin sensitivity. The investigators hypothesis is that proxy measures of IMAT via echointensity values will be positively associated with biomarkers of inflammation and insulin homeostasis.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
August 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Washington D.C. Veterans Affairs Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Michael Harris-Love

Principal Investigator

Washington D.C. Veterans Affairs Medical Center

Eligibility Criteria

Inclusion Criteria

  • You are eligible to participate 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).

Exclusion Criteria

  • You are not eligible to participate if:
  • You have uncontrolled hypertension.
  • Body Mass Index (BMI) \<18.5 or \>32.
  • 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.

Outcomes

Primary Outcomes

Sonographic Lean Body Mass

Time Frame: 1 day

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.

Secondary Outcomes

  • Intramuscular adipose tissue assessment(1 day)
  • DXA lean body mass(At time of assessment)
  • Functional assessment(1 day)
  • Metabolic status(1 day)
  • Physical activity questionnaire(1 day)
  • Strength assessment(1 day)

Study Sites (1)

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