- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02277236
Screening for Age-Related Skeletal Muscle Dysfunction (ARMS)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20422
- Washington DC VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
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Exclusion Criteria: You are not eligible to participate 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.
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Younger Veterans
Male Veterans, 45-64.9 years of age.
(Exposures include DXA scanning and CT imaging.)
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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).
Other Names:
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).
Other Names:
|
Young-Old Veterans
Male Veterans, 65-84.9 years of age.
(Exposures include DXA scanning and CT imaging.)
|
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).
Other Names:
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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity questionnaire
Time Frame: 1 day
|
Participants will also complete the International Physical Activity Questionnaire (IPAQ) to obtain an estimate of their customary activity and formal exercise.
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1 day
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Metabolic status
Time Frame: 1 day
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A blood sample (60 cc) will be obtained after an 8-hour overnight fast: glucose and insulin levels will be assessed before and during a standard (75 g) 2 hour oral glucose tolerance test.
Other laboratory values such as a standard lipid profile and selected cytokines (IL-6), will also be measured.
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1 day
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DXA lean body mass
Time Frame: At time of assessment
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Participants will undergo dual energy X-ray absorptiometry (DXA) scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total LBM, and body fat percentage (BF%).
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At time of assessment
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Intramuscular adipose tissue assessment
Time Frame: 1 day
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Estimates of intramuscular adipose tissue (IMAT) will be obtained with CT imaging.
A single, unilateral 10mm axial image slice (120 kVp, 200 to 250 mA) of the thigh will be obtained at the midfemur region (corresponding to the ultrasound scanning site).
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1 day
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Strength assessment
Time Frame: 1 day
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Grip strength will be assessed bilaterally; isokinetic knee extension/flexion torques will be obtained bilaterally using the Biodex System 4. Peak concentric torque (at 60º/s and 180º/s) will be obtained in a randomized fashion with subject positioning and stabilization per the Biodex Operations Manual.
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1 day
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Functional assessment
Time Frame: 1 day
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A standardized timed sit-to-stand test will be conducted (5 repetitions); 6m walking speed (habitual and fast gait) will be recorded; the Physical Performance Test (PPT-7), a functional battery validated for use with older adults, will be used in this study to assess the activities of daily living of the participants.
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1 day
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Collaborators and Investigators
Investigators
- Principal Investigator: Michael Harris-Love, MPT, DSc, Washington DC VA Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIRB01671
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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