Immune Cells During Disuse and Recovery

Muscle Disuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416191
• Other study ID #: 130232
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: April 30, 2028

Study information

• Verified date: March 2024
• Source: University of Utah
• Contact: Micah Drummond, PhD
• Phone: 801-213-2737
• Email: micah.drummond[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Disuse

Intervention

Other:
• Limb immobilization
Participants will undergo a 2-week period of leg immobilization

Locations

Country	Name	City	State
United States	The University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

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