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Immune Cells During Disuse and Recovery

Muscle Immune Cells During Disuse and Recovery in Aging and Metabolic Disease

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04416191
Enrollment
45
Registered
2020-06-04
Start date
2022-05-15
Completion date
2028-04-30
Last updated
2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Disuse

Brief summary

This is an interventional study enrolling healthy individuals aged 18-35 and 60-85 to understand the recovery of muscle health following a period of inactivity. The enrollment goal is 45 participants. The study will occur over the course of 1-2 months where participants will undergo testing before and after a 2-week limb immobilization period.

Detailed description

Visit 1 (Pre-testing)- After signing a consent form, participants will undergo a blood screening and an oral glucose tolerance test. After the visit, participants will be provided with a step activity monitor to track their level of activity. A dietary assessment will also be determined. Visit 2- At a later time, the participant will return to the research center for a biopsy, blood draw, body composition scan, MRI and muscle strength testing. 2-week leg immobilization period- After visit 2 , the participant will return home and undergo a 14-day leg immobilization period using the equipment and instructions provided at visit 2. Visit 3- During the limb immobilization period, participant will return to the research center for a single blood draw. Visit 4- At the end of the 2-week limb immobilization period, the participant will return to the research center to undergo another biopsy, blood draw, body composition scan, MRI and muscle strength testing. Visit 5- 2 days after the 2-week limb immobilization period, the participant will return for a biopsy and blood draw. Visit 6- 7 days after the 2-week limb immobilization period, the participant will be asked to return for a final biopsy, blood draw, body composition scan, MRI and muscle strength testing.

Interventions

OTHERLimb immobilization

Participants will undergo a 2-week period of leg immobilization

Sponsors

University of Utah
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Participants will be tested before a 2-week limb immobilization period

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age between 18-35 and 60-85 yrs 2. Ability to sign informed consent 3. Free-living, prior to admission

Exclusion criteria

* History of cardiovascular disease (e.g., CHF, CAD, right-to-left shunt) * History of endocrine or metabolic disease such as hypo/hyperthyroidism and diabetes * History of kidney disease or failure * Vascular disease * Risk of DVT including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb\>18 g/dL) or thrombocytosis (platelets\>400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocystinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombine III * Use of anticoagulant therapy (e.g., Coumadin, heparin) * Elevated systolic pressure \>150 or a diastolic blood pressure \> 100 * Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators) * Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma * Currently on a weight-loss diet * Chronic systemic corticosteroid use (≥ 2 weeks) within 4 weeks of enrollment and for study duration (intra-articular/topical/inhaled therapeutic or physiologic doses of corticosteroids are permitted) * Androgens or growth hormone within 6 months of enrollment and for study duration (topical physiologic androgen replacement is permitted) * History of stroke with motor disability * A recent history (\<12 months) of GI bleed * History of liver disease * History of respiratory disease (acute upper respiratory infection, history of chronic lung disease) * Pregnancy as determined by a pregnancy test * Any staff members who report directly to an investigator or who report to someone who reports directly to an investigator. * Any other condition or event considered exclusionary by the PI and faculty physician

Design outcomes

Primary

MeasureTime frameDescription
Thigh Muscle Volumebaseline and after 2 weeks of leg immobilizationchange in thigh muscle volume as determined by MRI
Leg Muscle Strengthbaseline and after 2 weeks of leg immobilizationchange in isometric leg extension strength as determined by a isokinetic dynamometer

Countries

United States

Contacts

Primary ContactMicah Drummond, PhD
micah.drummond@hsc.utah.edu801-213-2737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026