SarcopeniaARMSNCT02277236
Screening for Age-Related Skeletal Muscle Dysfunction
An observational study of Sarcopenia, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- DXA scanning and CT imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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).
- -
Who cannot join
- 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.
Show all 10Show fewer
- Uncontrolled cardiovascular disease.
- Hospitalization over the last three months.
- Diagnosis of diabetes.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
About this study
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
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- DXA scanning, CT imaging
- Keywords
- sarcopenia, aging, insulin resistance, screening
- Medical subject headings
- Sarcopenia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DXA scanningRadiation
Also called Radiograph, x-rays
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).
CT imagingRadiation
Also called CAT scan
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).
| Study group | Role | What they receive |
|---|---|---|
| Younger Veterans | Male Veterans, 45-64.9 years of age. (Exposures include DXA scanning and CT imaging.) Receives: Radiation: DXA scanning; Radiation: CT imaging | |
| Young-Old Veterans | Male Veterans, 65-84.9 years of age. (Exposures include DXA scanning and CT imaging.) Receives: Radiation: DXA scanning; Radiation: CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (6)
Metabolic status
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.
Measured: 1 day
DXA lean body mass
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%).
Measured: At time of assessment
Intramuscular adipose tissue assessment
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).
Measured: 1 day
Strength assessment
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.
Measured: 1 day
Functional assessment
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.
Measured: 1 day
Physical activity questionnaire
Participants will also complete the International Physical Activity Questionnaire (IPAQ) to obtain an estimate of their customary activity and formal exercise.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2017
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center
- Investigators
- Michael Harris-Love, MPT, DSc, Principal investigator, Washington DC VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277236
- Sponsor's protocol ID
- MIRB01671
- Acronym
- ARMS
- Status last verified
- Dec 2019
- First submitted
- 18 Oct 2014
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25071595Harris-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.
PubMed 25071570Gollie 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.
PubMed 34708217
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02277236
- Acronym / sponsor ID
- ARMS / MIRB01671
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, aging, insulin resistance, screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Study start
- Oct 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Aug 2020 (estimated)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger Veterans | – | Radiation: DXA scanning, Radiation: CT imagingMale Veterans, 45-64.9 years of age. (Exposures include DXA scanning and CT imaging.) |
| Young-Old Veterans | – | Radiation: DXA scanning, Radiation: CT imagingMale Veterans, 65-84.9 years of age. (Exposures include DXA scanning and CT imaging.) |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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).
- -
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DXA scanningAlso: Radiograph, x-raysExposure: 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). | Radiation | Young-Old Veterans, Younger Veterans |
| CT imagingAlso: CAT scanExposure: 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). | Radiation | Young-Old Veterans, Younger Veterans |
Primary outcome
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.
6 secondary outcomes
Metabolic status
Time frame: 1 day
DXA lean body mass
Time frame: At time of assessment
Intramuscular adipose tissue assessment
Time frame: 1 day
Strength assessment
Time frame: 1 day
Functional assessment
Time frame: 1 day
Physical activity questionnaire
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Background: PubMed 25071595Harris-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.
- Background: PubMed 25071570Harris-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.
- Derived from this study: PubMed 34708217Gollie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Harris-Love, MPT, DSc principal investigator
Washington DC VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sonographic Lean Body Mass (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02277236, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.