SarcopeniaNCT02116166
Skeletal Muscle Inflammation, Oxidative Stress and DNA Repair in Age-Related Sarcopenia
An observational study of Sarcopenia, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to investigate how and why the loss of muscle mass occurs with aging. Tissue collected from young subjects will be compared to previously collected tissue from elderly subjects, as well as previously collected data on muscle function/mass to further investigate cellular and… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 2016
- Phase
- Observational
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young (age 20-35 years; N =10)
Who may be able to join
- males and females aged 20-35.
- willing and able to give informed consent.
Who cannot join
- High physical activity level (i.e., the subject has spent greater than 300 minutes per week in the past 2 month performing structured physical activity, such as exercising at a gym and/or weight training)
- Active treatment for cancer or history of cancer in the past 3 years
- Congestive heart failure NYHA Class III or IV
- Previous stroke with upper and/or lower extremities involvement within the last 6 months
- Peripheral vascular disease Fontaine Class III/IV
- History of life-threatening cardiac arrhythmias, stroke, severe Parkinson's disease or severe neurological disorders likely to interfere with physical function
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- Renal disease requiring dialysis
- Lung disease requiring steroids
- Lower extremity amputation
- Complicated diabetes
- Life-threatening illnesses with an estimated life expectancy less than 1 year
- Anticoagulant therapy (aspirin use is allowed, but participants will be asked to stop taking it 48 hours prior to muscle biopsy)
- Involved in active weight loss > 5 kg in prior 3 months
- Pregnancy (determined by a pregnancy test)
- Lidocaine allergy
- Temporary exclusion criteria:
- Recent bacterial infection (< 2 weeks)
- Acute febrile illness in previous 2 months
- High blood pressure (i.e., BP ≥ 160/90 mm Hg) at the visit (subject will be referred to his/her physician and reevaluated after appropriated therapy being instituted)
- Taking aspirin within 48 hours preceding biopsy
- Performing exercise 48 hours prior to the biopsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Claude D. Pepper Older Americans Independence Center (OAIC); Skeletal Muscle Inflammation, Oxidative Stress and DNA Repair in Age-Related Sarcopenia
The purpose of this research study is to investigate how and why the loss of muscle mass occurs with aging. Tissue collected from young subjects will be compared to previously collected tissue from elderly subjects, as well as previously collected data on muscle function/mass to further investigate cellular and molecular pathways that have recently been shown to be important for the aging process in muscle. The Principal Investigator (PI) and the study team will look for specific proteins (called biomarkers) that can be present in the muscle tissue in various amounts in different individuals. This study will increase the investigators understanding of the processes of muscle atrophy (loss of mass) and functional loss at older age and will help to find new treatments and interventions aimed at improving the quality of life and independence of America's rapidly expanding elderly population.
Read the detailed description
For this project, we will continue to gain mechanistic insight into age-related muscle loss and to maximize the utility of the tissue we previously collected (Claude D. Pepper Older Americans Independence Center (OAIC); Skeletal muscle apoptosis and physical performance; Oxidative RNA/DNA damage and repair in aged human muscle (Developmental Study), IRB # 429-2005) and we will collect muscle tissue from additional young subjects. This project will specifically test whether inflammatory pathways and DNA repair mechanisms are altered and/or involved in the development of sarcopenia and the related decline in physical function observed in the elderly.
Aim 1. We will further determine the association of skeletal muscle mass and function with intramuscular mediators of inflammation. Focus will be on inflammatory proteins (e.g.,TNF, TNFR1, pIkBα, pIKKb, CCL2, ZIP14, ZnT2) and genes (e.g., IL-6, TNFa, IL11β, IL-8, CCL2, CCR2, NFkB p50, NFkB p65, ZIP14) and metals (e.g., copper, zinc, and iron). We hypothesize that the majority of these markers will be upregulated in muscle from older individuals when compared to young.
Aim 2. For the first time, we will determine the age related effect of DNA damage on pattern and dynamics of mRNA translation in human muscle tissue by genome wide analysis using "ribosome profiling." The recently developed deep-sequencing techniques of RNA-seq and "ribosome profiling" will be implemented on human muscle. This will allow us to explore on a genomic scale and at single-nucleotide resolution, the effect of age-related DNA damage on transcriptional fidelity and translational kinetics. Importantly, for the first time, these phenotype changes will be compared with genome mapping of DNA damage, a major factor driving mammalian aging. We hypothesize that older muscle has greater modification of translational patterns compared to young muscle.
Muscle tissue samples remaining following the completion of this research will be stored and used in the future to explore new avenues of research related to aging.
- Conditions
- Sarcopenia
- Keywords
- aging, sarcopenia, mitochondria, skeletal muscle, inflammation
- Medical subject headings
- Sarcopenia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young | Young (20-35 years old) | |
| Old | Older (70-99 years old) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Necrosis Factor alpha (TNF-alpha)
Inflammation marker; measured in muscle biopsy specimens.
Measured: baseline
tumor-necrosis factor receptor-1 (TNFR1)
Inflammation marker; measured in muscle biopsy specimens.
Measured: baseline
Phospho-Inhibitory Subunit Of NF-KBα (pIkBα)
Inflammation marker; measured in muscle biopsy specimens.
Measured: baseline
Chemokine (C-C motif) ligand 2 (CCL2)
Inflammation marker; measured in muscle biopsy specimens.
Measured: baseline
zinc transporter (ZIP) 14
Inflammation marker; measured in muscle biopsy specimens.
Measured: baseline
Interleukin 6 (IL-6)
Inflammation marker; measured in muscle biopsy specimens.
Measured: baseline
Interleukin (IL) 11β
Inflammation marker; measured in muscle biopsy specimens.
Measured: baseline
Interleukin 8 (IL-8)
Inflammation marker; measured in muscle biopsy specimens.
Measured: baseline
C-C chemokine receptor type 2 (CCR2)
Inflammation marker; measured in muscle biopsy specimens.
Measured: baseline
zinc transporter 14 (ZIP14)
Inflammation marker; measured in muscle biopsy specimens.
Measured: baseline
copper
metals; measured in muscle biopsy specimens.
Measured: baseline
zinc
metals; measured in muscle biopsy specimens.
Measured: baseline
iron
metals; measured in muscle biopsy specimens.
Measured: baseline
ribosome profiling
DNA damage on pattern and dynamics of mRNA translation in human muscle tissue; measured in muscle biopsy specimens.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Christiaan Leeuwenburgh, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116166
- Sponsor's protocol ID
- 201300790-N
- Other IDs
- 2P30AG028740
- Status last verified
- Apr 2018
- First submitted
- 14 Apr 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Claude D. Pepper Older Americans Independence Center (OAIC); Skeletal Muscle Inflammation, Oxidative Stress and DNA Repair in Age-Related Sarcopenia
- ClinicalTrials.gov ID
- NCT02116166
- Acronym / sponsor ID
- 201300790-N
- Conditions
- Sarcopenia
- Keywords
- aging, sarcopenia, mitochondria, skeletal muscle, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Apr 2014 (estimated)
- 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 purpose of this research study is to investigate how and why the loss of muscle mass occurs with aging. Tissue collected from young subjects will be compared to previously collected tissue from elderly subjects, as well as previously collected data on muscle function/mass to further investigate cellular and molecular pathways that have recently been shown to be important for the aging process in muscle. The Principal Investigator (PI) and the study team will look for specific proteins (called biomarkers) that can be present in the muscle tissue in various amounts in different individuals. This study will increase the investigators understanding of the processes of muscle atrophy (loss of mass) and functional loss at older age and will help to find new treatments and interventions aimed at improving the quality of life and independence of America's rapidly expanding elderly population.
Detailed description
For this project, we will continue to gain mechanistic insight into age-related muscle loss and to maximize the utility of the tissue we previously collected (Claude D. Pepper Older Americans Independence Center (OAIC); Skeletal muscle apoptosis and physical performance; Oxidative RNA/DNA damage and repair in aged human muscle (Developmental Study), IRB # 429-2005) and we will collect muscle tissue from additional young subjects. This project will specifically test whether inflammatory pathways and DNA repair mechanisms are altered and/or involved in the development of sarcopenia and the related decline in physical function observed in the elderly.
Aim 1. We will further determine the association of skeletal muscle mass and function with intramuscular mediators of inflammation. Focus will be on inflammatory proteins (e.g.,TNF, TNFR1, pIkBα, pIKKb, CCL2, ZIP14, ZnT2) and genes (e.g., IL-6, TNFa, IL11β, IL-8, CCL2, CCR2, NFkB p50, NFkB p65, ZIP14) and metals (e.g., copper, zinc, and iron). We hypothesize that the majority of these markers will be upregulated in muscle from older individuals when compared to young.
Aim 2. For the first time, we will determine the age related effect of DNA damage on pattern and dynamics of mRNA translation in human muscle tissue by genome wide analysis using "ribosome profiling." The recently developed deep-sequencing techniques of RNA-seq and "ribosome profiling" will be implemented on human muscle. This will allow us to explore on a genomic scale and at single-nucleotide resolution, the effect of age-related DNA damage on transcriptional fidelity and translational kinetics. Importantly, for the first time, these phenotype changes will be compared with genome mapping of DNA damage, a major factor driving mammalian aging. We hypothesize that older muscle has greater modification of translational patterns compared to young muscle.
Muscle tissue samples remaining following the completion of this research will be stored and used in the future to explore new avenues of research related to aging.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young | – | –Young (20-35 years old) |
| Old | – | –Older (70-99 years old) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young (age 20-35 years; N =10)
Key inclusion criteria (2 listed)
- males and females aged 20-35.
- willing and able to give informed consent.
Key exclusion criteria (21 listed)
- High physical activity level (i.e., the subject has spent greater than 300 minutes per week in the past 2 month performing structured physical activity, such as exercising at a gym and/or weight training)
- Active treatment for cancer or history of cancer in the past 3 years
- Congestive heart failure NYHA Class III or IV
- Previous stroke with upper and/or lower extremities involvement within the last 6 months
- Peripheral vascular disease Fontaine Class III/IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tumor Necrosis Factor alpha (TNF-alpha)
Time frame: baseline
Inflammation marker; measured in muscle biopsy specimens.
tumor-necrosis factor receptor-1 (TNFR1)
Time frame: baseline
Inflammation marker; measured in muscle biopsy specimens.
Phospho-Inhibitory Subunit Of NF-KBα (pIkBα)
Time frame: baseline
Inflammation marker; measured in muscle biopsy specimens.
Chemokine (C-C motif) ligand 2 (CCL2)
Time frame: baseline
Inflammation marker; measured in muscle biopsy specimens.
zinc transporter (ZIP) 14
Time frame: baseline
Inflammation marker; measured in muscle biopsy specimens.
Interleukin 6 (IL-6)
Time frame: baseline
Inflammation marker; measured in muscle biopsy specimens.
Interleukin (IL) 11β
Time frame: baseline
Inflammation marker; measured in muscle biopsy specimens.
Interleukin 8 (IL-8)
Time frame: baseline
Inflammation marker; measured in muscle biopsy specimens.
C-C chemokine receptor type 2 (CCR2)
Time frame: baseline
Inflammation marker; measured in muscle biopsy specimens.
zinc transporter 14 (ZIP14)
Time frame: baseline
Inflammation marker; measured in muscle biopsy specimens.
copper
Time frame: baseline
metals; measured in muscle biopsy specimens.
zinc
Time frame: baseline
metals; measured in muscle biopsy specimens.
iron
Time frame: baseline
metals; measured in muscle biopsy specimens.
ribosome profiling
Time frame: baseline
DNA damage on pattern and dynamics of mRNA translation in human muscle tissue; measured in muscle biopsy specimens.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- University of Florida Claude D. Pepper Older Americans Independence Center (OAIC)Link provided by the sponsor.
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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.
Christiaan Leeuwenburgh, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia, run by University of Florida 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 2 inclusion and 21 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: finished, as of the sponsor's last update on 5 Apr 2018. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tumor Necrosis Factor alpha (TNF-alpha) (time frame: baseline). The study lists 14 primary outcomes in all. 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 5 Apr 2018.