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

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ClinicalTrials.gov Identifier: NCT03839628
Recruitment Status : Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Micah Drummond, University of Utah

Tracking Information
First Submitted Date  ICMJE February 11, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 27, 2020
Actual Study Start Date  ICMJE March 5, 2019
Estimated Primary Completion Date December 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • Lean Mass [ Time Frame: baseline and 2-weeks ]
    Change in lean mass
  • Strength [ Time Frame: baseline and 2-weeks ]
    Change in muscle strength
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Translational Control of Anabolic Resistance in Aging Muscle
Official Title  ICMJE Translational Control of Anabolic Resistance in Aging Muscle
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Physical Inactivity
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Reduced Physical Activity
Participants will reduce their physical activity levels for 2-weeks by approximately 75% of their baseline level of physical activity
Intervention: Other: Reduced Physical Activity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 17, 2020)
8
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2019)
15
Estimated Study Completion Date  ICMJE December 17, 2021
Estimated Primary Completion Date December 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03839628
Other Study ID Numbers  ICMJE Leucine study
R21AR073422 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan has been put into place
Responsible Party Micah Drummond, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Micah Drummond University of Utah
PRS Account University of Utah
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP