Autophagy and Apoptosis in Human Satellite CellsNCT03473288
Rejuvenation of Aged Muscle Stem Cells Through Exercise
A study testing Exercise and Sedentary in people with Autophagy and Apoptosis in Human Satellite Cells, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autophagy and Apoptosis in Human Satellite Cells
- What is being tested?
- Exercise and Sedentary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 6 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 years or greater.
- No medication changes within the last 3 months.
- Not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week).
- Able to decide if you want to take part in the study.
Who cannot join
- Smoker: Tobacco use within the last 12 months.
- Dieting or intending to diet.
- Use of potential confounding medications, e.g. using ticlopidine, clopidogrel, dipyridamole, warfarin, heparin, enoxaparin and other blood thinners.
- Coronary stents or any other medical condition for which aspirin cannot be temporarily withheld.
- Use of hormone replacement medications.
- Absolute contra-indications to exercise: Recent (<6 months) acute cardiac event unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurysm and acute systemic infection.
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- Relative contra-indications to exercise: Left main coronary stenosis, moderate stenotic valvular heart disease, outflow tract obstruction, high degree AV block, ventricular aneurysm, uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxedema), uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis), mental or physical impairment leading to inability to exercise adequately.
- Have a confounding medical condition that is progressive and unstable such as HIV, Hepatitis C, active cancer, and/or taking medications for those conditions.
- Unwillingness to be randomized to any one of two intervention groups, submit to skeletal muscle biopsies and all other study testing or continuously participate in a randomly assigned exercise training or program for three months.
- Orthopedic limitations, musculoskeletal disease and/or injury.
- Allergic to xylocaine.
- Unwillingness to exercise at the Duke Center for Living during staff supervised times.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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-6/TNF/IL-1) and endocrine markers (Testosterone/Estrogen/Thyroid 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 p<.05. 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 and/or bruising. In addition, there is a minimal risk of infection, excess bleeding, clotting, and fainting. An exercise program may result in muscle, bone and/or joint soreness, discomfort and/or 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.
- Being tested
- Exercise, Sedentary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will undergo supervised exercise 3 times a week for 10-12 weeks.
SedentaryBehavioural
Participants will be asked to maintain the sedentary lifestyle that they already have for 10-12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Intensity Treadmill Exercise | Active comparator | Moderate intensity treadmill exercise three times per week for 10-12 weeks Receives: Behavioral: Exercise |
| Sedentary Controls | Placebo comparator | Serve as a sedentary (little exercise) control for 10-12 weeks Receives: Behavioral: Sedentary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Stem Cell Function by Age Group
Muscle stem cell function will be compared across age groups at baseline, post-acute (1 week after baseline), and post-chronic (12 weeks after baseline) using a One Way ANOVA or t test for specific comparisons
Measured: Baseline, 1 Week Post Baseline, and 12 Weeks Post Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Jan 2021 (estimated)
- Primary completion6 Jun 2021
- Study completion6 Jun 2021
Why it stopped: No enrollment due to COVID restrictions and funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autophagy and Apoptosis in Human Satellite CellsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- James White, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473288
- Sponsor's protocol ID
- Pro00084763
- Other IDs
- 1K01AG056664
- Status last verified
- Jun 2021
- First submitted
- 15 Mar 2018
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rejuvenation of Aged Muscle Stem Cells Through Exercise
- ClinicalTrials.gov ID
- NCT03473288
- Acronym / sponsor ID
- Pro00084763
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment due to COVID restrictions and funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 6 Jun 2021 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-6/TNF/IL-1) and endocrine markers (Testosterone/Estrogen/Thyroid 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 p<.05. 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 and/or bruising. In addition, there is a minimal risk of infection, excess bleeding, clotting, and fainting. An exercise program may result in muscle, bone and/or joint soreness, discomfort and/or 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Intensity Treadmill Exercise | Active comparator | Behavioral: ExerciseModerate intensity treadmill exercise three times per week for 10-12 weeks |
| Sedentary Controls | Placebo comparator | Behavioral: SedentaryServe as a sedentary (little exercise) control for 10-12 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 years or greater.
- No medication changes within the last 3 months.
- Not participating in regular physical exercise (more than 60 minutes of moderate intensity or 30 minutes of vigorous intensity exercise per week).
- Able to decide if you want to take part in the study.
Key exclusion criteria (12 listed)
- Smoker: Tobacco use within the last 12 months.
- Dieting or intending to diet.
- Use of potential confounding medications, e.g. using ticlopidine, clopidogrel, dipyridamole, warfarin, heparin, enoxaparin and other blood thinners.
- Coronary stents or any other medical condition for which aspirin cannot be temporarily withheld.
- Use of hormone replacement medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants will undergo supervised exercise 3 times a week for 10-12 weeks. | Behavioural | Moderate Intensity Treadmill Exercise |
| SedentaryParticipants will be asked to maintain the sedentary lifestyle that they already have for 10-12 weeks. | Behavioural | Sedentary Controls |
Primary outcome
Change in Muscle Stem Cell Function by Age Group
Time frame: Baseline, 1 Week Post Baseline, and 12 Weeks Post Baseline
Muscle stem cell function will be compared across age groups at baseline, post-acute (1 week after baseline), and post-chronic (12 weeks after baseline) using a One Way ANOVA or t test for specific comparisons
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James White, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Sedentary in people with Autophagy and Apoptosis in Human Satellite Cells, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Stem Cell Function by Age Group (time frame: Baseline, 1 Week Post Baseline, and 12 Weeks Post Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.