Immune Cells During Disuse and Recovery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Disuse
• Intervention / Treatment: Other: Limb immobilization

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Micah Drummond, PhD; Phone Number: 801-213-2737; Email: micah.drummond@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • The University of Utah
      • Contact: Micah Drummond, PhD; Phone Number: 801-587-7764
      • Contact: Email: micah.drummond@hsc.utah.edu
      • Principal Investigator: Micah Drummond

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Limb immobilization; Participants will undergo a 2-week leg immobilization period	Other: Limb immobilization; Participants will undergo a 2-week period of leg immobilization; Other Names: Muscle Disuse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thigh Muscle Volume	change in thigh muscle volume as determined by MRI	baseline and after 2 weeks of leg immobilization
Leg Muscle Strength	change in isometric leg extension strength as determined by a isokinetic dynamometer	baseline and after 2 weeks of leg immobilization

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Micah Drummond, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 130232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan has been put into place

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No