Translational Control of Anabolic Resistance in Aging Muscle

NCT03839628 | Completed Results DMC

• 2 other identifiers: Leucine studyR21AR073422
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional study enrolling older individuals aged 60-85y to observe changes during physical inactivity. This study is investigating the relation between short-term physical inactivity and the impact of muscle health and function. The enrollment goal is 8 participants. The study will occur over the course of a month where participants will undergo testing before and after a reduction in physically activity levels. There will be a screening event collecting baseline data, two body composition scans, muscle function and oral glucose tolerance tests and a metabolic study before and after a 2-week period of inactivity. Each metabolic study will entail three-muscle biopsies: one before and 2 after the ingestion of leucine.

Conditions

Physical Inactivity

Outcome Measures

Primary Outcomes (2)

• Lean Mass

  Change in lean mass

  baseline and 2-weeks

• Strength

  Change in muscle strength

  baseline and 2-weeks

Study Arms (1)

Reduced Physical Activity

EXPERIMENTAL

Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity

Other: Reduced Physical Activity

Interventions

Reduced Physical Activity OTHER

Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.

Also known as: Muscle Disuse

Reduced Physical Activity

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 60-85 years
• Ability to sign informed consent
• Free-living, prior to admission

You may not qualify if:

• Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
• History of kidney disease or failure
• Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia \> 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries)
• Risk of blood clotting including family history of thrombophilia, 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
• Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
• Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
• Currently on a weight-loss diet or body mass index \> 30 kg/m2
• 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)
• Prior history of Heparin-Induced Thrombocytopenia

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Micah Drummond
• Organization: The University of Utah

micah.drummond@hsc.utah.edu

801-213-2737

Study Officials

• Micah Drummond

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be tested before and 2-weeks after they have reduced their level of physical activity

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: March 5, 2019
• Primary Completion: December 17, 2019
• Study Completion: December 17, 2019
• Last Updated: June 22, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)