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Trial record 1 of 1 for:    NCT03839628
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Translational Control of Anabolic Resistance in Aging Muscle

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03839628
Recruitment Status : Completed
First Posted : February 15, 2019
Results First Posted : June 2, 2022
Last Update Posted : June 22, 2022
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Micah Drummond, University of Utah

Study Description
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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.

Condition or disease Intervention/treatment Phase
Physical Inactivity Other: Reduced Physical Activity Not Applicable

Detailed Description:

Pre-testing- The baseline evaluation will assess muscle function and strength, and an oral glucose tolerance test. After the baseline visit, participants will be provided with a step activity monitor to track their level of activity. This will provide a baseline of the participant's normal level of physical activity so an accurate level of 75% activity reduction can be determined. A 3-day daily dietary diary will be provided for the participant to self-report prior to the experiment, as well.

Day 1- After the participant completes their normal activity log and dietary diary, they will be asked to return to the research center for a body composition scan and a metabolic study.

The metabolic study will involve blood sampling from an arm vein and muscle biopsies from the thigh before and after a leucine drink.

2-week period of inactivity- After the metabolic study, the participant will return home and maintain a reduced level of activity (75% reduction) for a two-week period. During this time, the participant will receive phone calls from research personnel in order to maintain adherence to the intervention.

Day 14- After the 2-week reduced activity period, the participant will return to the research center to receive a body composition scan and undergo a metabolic study identical to 'Day 1'.

Post-testing- After Day 14, the participant will be asked to return once again to the research center for a oral glucose tolerance test and the exercise lab for muscle function testing.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Participants will be tested before and 2-weeks after they have reduced their level of physical activity
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Translational Control of Anabolic Resistance in Aging Muscle
Actual Study Start Date : March 5, 2019
Actual Primary Completion Date : December 17, 2019
Actual Study Completion Date : December 17, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Reduced Physical Activity
Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity
 Other: Reduced Physical Activity
Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.
Other Name: Muscle Disuse


Outcome Measures
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Primary Outcome Measures :
  1. Lean Mass [ Time Frame: baseline and 2-weeks ]
    Change in lean mass

  2. Strength [ Time Frame: baseline and 2-weeks ]
    Change in muscle strength


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Cardiac abnormalities considered exclusionary by the study physician (e.g., Chronic heart Failure, right-to-left shunt)
  • 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
  • An HbA1c value at or greater than 6.5%
  • Any other condition or event considered exclusionary by the PI and faculty physician
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03839628


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Micah Drummond University of Utah
  Study Documents (Full-Text)

Documents provided by Micah Drummond, University of Utah:
Study Protocol  [PDF] July 24, 2018
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Responsible Party: Micah Drummond, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03839628    
Other Study ID Numbers: Leucine study
R21AR073422 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Results First Posted: June 2, 2022
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan has been put into place

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No