MedDataX Logo

Screening for Age-Related Skeletal Muscle Dysfunction

NCT ID: NCT02277236

Last Updated: 2019-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcopenia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sarcopenia aging insulin resistance screening

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Younger Veterans

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

DXA scanning

Intervention Type RADIATION

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 imaging

Intervention Type RADIATION

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).

Young-Old Veterans

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

DXA scanning

Intervention Type RADIATION

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 imaging

Intervention Type RADIATION

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DXA scanning

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).

Intervention Type RADIATION

CT imaging

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).

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Radiograph, x-rays CAT scan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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).

\-

Exclusion Criteria

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.

\-
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Washington D.C. Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Harris-Love

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Harris-Love, MPT, DSc

Role: PRINCIPAL_INVESTIGATOR

Washington DC VA Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Washington DC VA Medical Center

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

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25071595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25071570 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34708217 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MIRB01671

Identifier Type: -

Identifier Source: org_study_id