Viewing Study NCT03473288



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Last Modification Date: 2024-10-26 @ 12:42 PM
Study NCT ID: NCT03473288
Status: WITHDRAWN
Last Update Posted: 2021-06-10
First Post: 2018-03-15

Brief Title: Rejuvenation of Aged Muscle Stem Cells Through Exercise
Sponsor: Duke University
Organization: Duke University

Study Overview

Official Title: Rejuvenation of Aged Muscle Stem Cells Through Exercise
Status: WITHDRAWN
Status Verified Date: 2021-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: No enrollment due to COVID restrictions and funding issues
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The proposed study will establish a newly-identified signaling pathway regulating both autophagy and apoptosis in human satellite cells These findings will allow for novel pharmacological targets in satellite cells to return regenerative capacity to elderly individuals Up to 80 adults 21 years of age and greater will undergo a consent visit followed by three blood draws and muscle biopsy visits- baseline pre after the first exercise bout post-acute and after the 12 week training program post-chronic Blood will be obtained and tested for inflammatory IL-6TNFIL-1 and endocrine markers TestosteroneEstrogenThyroid hormone As part of the intervention participants will undergo moderate intensity treadmill exercise three times per week for 10-12 weeks or serve as sedentary controls Muscle stem cell function will be compared across age groups at each time point using a One Way ANOVA or t test for specific comparisons An alternative analysis will be a longitudinal design following muscle stem cell function from each individual before and after exercise training This analysis will be performed with repeated measure ANOVAs Data will be analyzed using GraphPad Prism 6 statistical software Significance will be accepted as p05 Thigh Muscle biopsies may result in momentary pain and discomfort burning or bleeding numbness and rarely fainting or infection The incision site may leave a scar and muscle soreness may be present up to ten days after the biopsy While the local numbing medicine xylocaine is almost entirely free from allergic properties such as causing hives an allergic reaction is possible and the participant will not be given xylocaine if they have a history of such a reaction The xylocaine will be given by a small injection into the skin at the site of the muscle biopsy Risks associated with a standard blood draw include momentary discomfort andor bruising In addition there is a minimal risk of infection excess bleeding clotting and fainting An exercise program may result in muscle bone andor joint soreness discomfort andor injury All collected data will be stored in a locked file to be accessed only by Dr White and his study staff Study records that identify subjects will be kept confidential as required by law
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1K01AG056664 NIH None httpsreporternihgovquickSearch1K01AG056664