Clinical trial NCT02277236: Screening for Age-Related Skeletal Muscle Dysfunction
Official title: Creating a Model of Proactive Geriatric Care Within VISN 5: Screening for Age-Related Skeletal Muscle Dysfunction at the Washington DC VA Medical Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Keywords: sarcopenia
aging
insulin resistance
screening
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2014-10-28
Enrollment: 30
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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).

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.

Eligibility criteria: Inclusion Criteria: You are eligible to participate if:

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

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Exclusion Criteria: You are not eligible to participate if:

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

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Primary outcomes:
measure: Sonographic Lean Body Mass
timeFrame: 1 day
Secondary outcomes:
measure: Metabolic status
timeFrame: 1 day
measure: DXA lean body mass
timeFrame: At time of assessment
measure: Intramuscular adipose tissue assessment
timeFrame: 1 day
measure: Strength assessment
timeFrame: 1 day
measure: Functional assessment
timeFrame: 1 day
measure: Physical activity questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
Study officials:
affiliation: Washington DC VA Medical Center
name: Michael Harris-Love, MPT, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.