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SarcopeniaNCT01644279

Skeletal Muscle Apoptosis and Physical Performance; Oxidative RNA/DNA Damage and Repair in Aged Human Muscle

An observational study of Sarcopenia, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The age-related loss of muscle mass and strength, also termed sarcopenia, is a commonly recognized consequence of aging and has been associated with frailty, functional loss, hospitalization, and increased mortality among older people. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia
How many people
63 participants
Where
1 siteUnited States
Study dates
Mar 2006to 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Young (age 20-35 years; N =20), old high-functioning, (age 70-99 years; N = 25), and old low-functioning (age 70-99 years; N = 20) subjects.

Who may be able to join

None listed.

Who cannot join

  • history of smoking in the prior 12 months
  • active treatment for cancer or history of cancer in the past 3 years
  • congestive heart failure New York Heart Association (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
Show all 30Show fewer
  • cognitive impairment (i.e., Mini-Mental State Examination (MMSE) ≤ 23)
  • renal disease requiring dialysis
  • lung disease requiring steroids
  • lower extremity amputation
  • severe osteoarthritis that interferes with physical function
  • Complicated diabetes
  • inflammatory diseases such as active rheumatoid arthritis, vasculitis, autoimmune disorders, and inflammatory bowel disease
  • life-threatening illnesses with an estimated life expectancy less than 1 year
  • history of drug or alcohol abuse
  • taking growth hormone (GH) and/or estrogen replacement therapy
  • Testosterone medication
  • Anticoagulant therapy
  • involved in active weight loss > 5 kg in prior 3 months
  • planning to relocate out of the study area in the next 4 years (ages 70-99 only)
  • pregnancy
  • SPPB score of 8-10
  • Lidocaine allergy
  • MRI exclusions, such as pregnancy, claustrophobia, heart pacemaker / defibrillator, heart valve prosthesis, aneurysm clip, metallic stent, neurostimulation system, cochlear implants or inner ear prosthesis, insulin pump or other infusion pump, metal slivers in the orbital area/eye socket
  • Temporary exclusion criteria:
  • recent bacterial infection (< 2 weeks)
  • acute febrile illness in prior 2 months
  • high blood pressure (i.e., BP ≥ 180/110 mm Hg) at the screening visit (subject will be referred to his/her physician and reevaluated after appropriated therapy being instituted)
  • major surgery or hip/knee replacement in the past 6 months
  • Assessment of disability. The uniform measure proposed to use for the assessment of disability will be a self-report disability questionnaire. This questionnaire was developed for the Fitness Arthritis in Seniors Trial (FAST) and since then has been widely used in intervention and observational studies (e.g. ADAPT, REACT-1, OASIS, CHAMP). The questionnaire is not specific to a certain disease and asks about perceived difficulties in general activities of daily living during the last month. Respondents answer for each of the items whether they experience 1) no difficulty, 2) a little difficulty, 3) some difficulty, 4) a lot of difficulty, 5) unable to do or, 6) did not do for other reasons. Answers can be averaged across the items in order to receive an indication of the overall perceived disability burden by a person.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Florida

    Gainesville, Florida, 32611

Other trials in United States

About this study

Official title: Claude D. Pepper Older Americans Independence Center (OAIC); Skeletal Muscle Apoptosis and Physical Performance; Oxidative RNA/DNA Damage and Repair in Aged Human Muscle

The age-related loss of muscle mass and strength, also termed sarcopenia, is a commonly recognized consequence of aging and has been associated with frailty, functional loss, hospitalization, and increased mortality among older people. Sarcopenia and its consequences have a considerable economic impact, since it has been estimated that the healthcare cost attributable to sarcopenia in the US in 2000 was $ 18.5 billions. Preclinical animal models strongly suggest that apoptosis, a programmed cell death, might play a prominent role in the age-related muscle wasting. In specific aim one, the investigators will assess the extent of muscle apoptosis in muscle biopsies obtained from the vastus lateralis muscle of young control subjects (ages 20-35) and high-performance and low-performance older subjects (age range 70-99 years). In specific aim 2, the investigators will investigate the role of Poly (ADP-ribose) polymerase 1 (PARP-1) and apoptosis-inducing factor (AIF) in the induction of skeletal muscle apoptosis. In specific aim 3, the investigators propose to investigate the contribution of the muscle energy deficit, due to the age-related mitochondrial dysfunction, in the development of muscle wasting. Finally, in specific aim 4, the investigators propose to reassess after four years physical performance, muscle mass and the extent of muscle apoptosis, in the high-performing participants, in order to correlate eventual decline in physical function, muscle mass and functional status, with changes in muscle apoptosis and in biochemical parameters in this very old population. Physical performance will be established according to the summary performance score obtained in the Short Form Physical Performance Battery (SPPB). In addition to the SPPB the investigators will also employ hand grip strength and knee extensor strength tests and the investigators will quantify muscle contractile area using 3D magnetic resonance imaging. Disability will be assessed using a self-report questionnaire. These studies will enhance our understanding of the biology and pathophysiology underlying the geriatric syndrome of sarcopenia and provide significant and novel insights that will enable us to identify new potential targets for interventions aimed at preventing and treating sarcopenia and functional impairment in older adults.

Read the detailed description

Specific Aims:

Specific Aim 1. To determine the extent of muscle apoptosis during aging in young healthy controls and in high-functioning and low-functioning older subjects. The investigators hypothesize that the observed level of muscle cell apoptosis is associated with physical disability. The investigators will recruit a cohort of ten young control subjects (age 20-35). The investigators will also recruit and stratify a cohort of forty elderly (age 70-99 years) into two distinct categories by set criteria based on their level of physical performance. Subjects with a summary performance score ≥ 11 at the Short Physical Performance Battery (SPPB) (66) will be considered high-functioning. Conversely, subjects with a summary performance score ≤ 7 will be considered low-functioning. In addition to the SPPB, the investigators will also perform the hand grip strength test and the isokinetic knee extensor test, and will implement 3D magnetic resonance imaging (MRI) to precisely quantify the quadriceps contractile area. The investigators will obtain a muscle biopsy for each subject to determine the severity of apoptosis using biochemical and histological analyses (see Methods). Disability will be assessed using a self-report questionnaire. Hence, the investigators will determine the extent muscle apoptosis and the investigators will be able to correlate this to the level of physical disability and muscle mass.

Specific Aim 2. To elucidate the role of Poly(ADP-ribose) polymerase 1 (PARP-1) and apoptosis-inducing factor (AIF) in the induction of apoptosis in human skeletal muscle. The investigators hypothesize that the observed cell loss due to apoptosis is mainly related to a caspase-independent mechanism. The investigators have recently shown that activation of mitochondrial caspase-independent pathway of apoptosis may play a more important role than the caspase-dependent pathway in contributing to nuclear cell death (67). Furthermore, the investigators hypothesize that the PARP-1/AIF pathway of apoptosis might be involved in the age-related muscle wasting process. The investigators will quantitatively assess PARP-1 and AIF and correlate these measures with the extent of muscle apoptosis.

Specific Aim 3. To assess the role of mitochondria dysfunction and energy failure in muscle apoptosis, sarcopenia, and disability. The investigators hypothesize that mitochondrial dysfunction and the resulting reduced production of adenosine triphosphate (ATP) is causally related to sarcopenia, possibly by triggering the apoptosis program. It has been estimated that the mean ATP production in the quadriceps muscle of old human subjects is approximately 50% of that of younger subjects (68), and it has been postulated that energy failure might trigger apoptosis (58). Consistently with these findings, the investigators have recently found that in rats' gastrocnemius muscle, ATP content and the rate of ATP production declined by ~50% with age (59). The investigators will quantitatively assess myocytes' ATP content along with key mitochondrial metabolic enzymes, namely citrate synthase, cytochrome-c-oxidase (COX), ATPase, and aconitase. The investigators will correlate these parameters with the level of apoptosis and with measures of physical performance, disability, and muscle mass.

Specific Aim 4. To correlate changes in physical function and muscle mass with muscle apoptosis and biochemical parameters at follow-up (longitudinal study). After 4 years subjects in the high-performance group will be reevaluated for muscle apoptosis rate, PARP-1 and AIF activity, and energy production. The investigators will correlate these parameters with measures of physical performance and muscle mass assessed by MRI, as well as with self-reported disability. Hence, the investigators will be able to directly correlate an eventual decline in physical performance, muscle mass and functional status at this very old age with changes in muscle apoptosis and in biochemical parameters.

Research Plan:

Using a cross-sectional design (age 20-35 and 70-99 years) the investigators will quantify the level of apoptosis in the vastus lateralis muscle in a healthy (see inclusion/exclusion criteria) population. Apoptosis of irreplaceable post-mitotic cells may be important mechanism in the development of sarcopenia and has not been investigated in healthy humans with age. A variety of chronic diseases have documented cases of apoptosis in human skeletal muscle; i.e., chronic pulmonary diseases (69,70) and patients with heart failure (69,71,72). However, it is essential to establish baseline levels of apoptosis in relatively healthy humans before proceeding to more complex conditions, such as disease conditions and frailty. In addition, the investigators will determine knee extensors strength, the myocyte volume, extra cellular space and the myonuclear domain (cross-sectional muscle area/nucleus) by quantifying the number of nuclei within a cross-sectional area of muscle. This specific aim will establish baseline levels of apoptosis and assess standard measures to assess sarcopenia.

Study design. To accomplish our aims, the investigators propose two separates, yet complementary studies

  1. In order to gain insights into changes of the apoptosis potential with age and its contribution to muscle mass and strength loss, the investigators will quantify the level of apoptosis in the vastus lateralis muscle in young (age 20-35 years; N =20), old high-functioning, (age 70-99 years; N = 25), and old low-functioning (age 70-99 years; N = 20) subjects. Muscle biopsy and MRI scan to quantify quadriceps contractile area will be performed in the study participants. Muscle strength will be assessed by hand grip strength test and the isokinetic knee extensor test.
  2. Preliminary data on the contribution of skeletal muscle apoptosis to sarcopenia, physical function loss in advanced age will be gathered by quantifying the extent of muscle apoptosis in the vastus lateralis muscle of old (age 70-99 years), high-functioning (N = 25) and low-functioning (N = 20) subjects, along with measures of muscle mass (MRI), muscle strength (hand grip and knee extension test), and overall physical performance (Short Physical Performance Battery, SPPB (67)). In addition, the investigators will collect preliminary data regarding the role mitochondrial-driven apoptosis in muscle wasting and functional loss at old age.

A brief physical exam will be administered to all study participants, and major biological signs (body weight, standing height, body temperature, blood pressure, and pulse) will be recorded. A basic questionnaire regarding participants' health history will also be administered

After four years the old participants will be reevaluated for physical performance, functional status muscle mass (MRI), muscle apoptosis, and biochemical parameters Disability will also be assessed using a self-report disability questionnaire. In order to gain information regarding changes in physical performance and functional status with time and to maximize retention, an annual visit employing SPPB, hand grip and knee extensor testing, will be scheduled for the old participants.

Conditions
Sarcopenia
Keywords
aging, sarcopenia, mitochondria, skeletal muscle, apoptosis
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01644279
Study groupRoleWhat they receive
YoungYoung (age 20-35 years old)
Old high-functioningOld high-functioning (age 70-99 years old)
Old low-functioningOld low-functioning (age 70-99 years old)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Short Form Physical Performance Battery (SPPB)

    The SPPB is composed by three subtasks: usual gait speed, standing balance and chair stand tests.

    Measured: baseline

  2. Cytochrome c oxidase activity

    Cytochrome c oxidase (COX) activity measured in permeabilized fibers from muscle biopsy specimens.

    Measured: baseline

  3. Muscle strength

    Muscle strength will be assessed by hand grip strength test and the isokinetic knee extensor test.

    Measured: baseline

  4. Quadriceps contractile area

    3D magnetic resonance imaging (MRI) to precisely quantify the quadriceps contractile area

    Measured: baseline

  5. Peroxisome proliferator-activated receptor γ coactivator α (PGC-1α)

    Major regulator of mitochondrial content and oxidative metabolism in several tissues, including skeletal muscle; measured in muscle biopsy specimens.

    Measured: baseline

  6. Sirtuin 3 (SIRT3)

    The induction of mitochondrial gene expression and biogenesis is largely controlled by the coordinated actions of various transcriptional and metabolic regulators including Sirtuin 3 (SIRT3); measured in muscle biopsy specimens.

    Measured: baseline

  7. Short Form Physical Performance Battery (SPPB)

    The SPPB is composed by three subtasks: usual gait speed, standing balance and chair stand tests.

    Measured: 4 years

  8. Cytochrome c oxidase activity

    Cytochrome c oxidase (COX) activity measured in permeabilized fibers from muscle biopsy specimens.

    Measured: 4 years

  9. Muscle strength

    Muscle strength will be assessed by hand grip strength test and the isokinetic knee extensor test.

    Measured: 4 years

  10. Quadriceps contractile area

    3D magnetic resonance imaging (MRI) to precisely quantify the quadriceps contractile area

    Measured: 4 years

  11. Peroxisome proliferator-activated receptor γ coactivator α (PGC-1α)

    Major regulator of mitochondrial content and oxidative metabolism in several tissues, including skeletal muscle; measured in muscle biopsy specimens.

    Measured: 4 years

  12. Sirtuin 3 (SIRT3)

    The induction of mitochondrial gene expression and biogenesis is largely controlled by the coordinated actions of various transcriptional and metabolic regulators including Sirtuin 3 (SIRT3); measured in muscle biopsy specimens.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2012 (estimated)
  2. Study startMar 2006
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01644279
Sponsor's protocol ID
429-2005
Other IDs
2P30AG028740
Status last verified
Nov 2016
First submitted
5 Jul 2012
Last updated
3 Nov 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Joseph AM, Adhihetty PJ, Buford TW, Wohlgemuth SE, Lees HA, Nguyen LM, Aranda JM, Sandesara BD, Pahor M, Manini TM, Marzetti E, Leeuwenburgh C. The impact of aging on mitochondrial function and biogenesis pathways in skeletal muscle of sedentary high- and low-functioning elderly individuals. Aging Cell. 2012 Oct;11(5):801-9. doi: 10.1111/j.1474-9726.2012.00844.x. Epub 2012 Jul 9.

    PubMed 22681576
  • Marzetti E, Lees HA, Manini TM, Buford TW, Aranda JM Jr, Calvani R, Capuani G, Marsiske M, Lott DJ, Vandenborne K, Bernabei R, Pahor M, Leeuwenburgh C, Wohlgemuth SE. Skeletal muscle apoptotic signaling predicts thigh muscle volume and gait speed in community-dwelling older persons: an exploratory study. PLoS One. 2012;7(2):e32829. doi: 10.1371/journal.pone.0032829. Epub 2012 Feb 28.

    PubMed 22389725
  • Buford TW, Lott DJ, Marzetti E, Wohlgemuth SE, Vandenborne K, Pahor M, Leeuwenburgh C, Manini TM. Age-related differences in lower extremity tissue compartments and associations with physical function in older adults. Exp Gerontol. 2012 Jan;47(1):38-44. doi: 10.1016/j.exger.2011.10.001. Epub 2011 Oct 12.

    PubMed 22015325
  • Marzetti E, Landi F, Marini F, Cesari M, Buford TW, Manini TM, Onder G, Pahor M, Bernabei R, Leeuwenburgh C, Calvani R. Patterns of circulating inflammatory biomarkers in older persons with varying levels of physical performance: a partial least squares-discriminant analysis approach. Front Med (Lausanne). 2014 Sep 1;1:27. doi: 10.3389/fmed.2014.00027. eCollection 2014.

    PubMed 25593902
  • Wawrzyniak NR, Joseph AM, Levin DG, Gundermann DM, Leeuwenburgh C, Sandesara B, Manini TM, Adhihetty PJ. Idiopathic chronic fatigue in older adults is linked to impaired mitochondrial content and biogenesis signaling in skeletal muscle. Oncotarget. 2016 Aug 16;7(33):52695-52709. doi: 10.18632/oncotarget.10685.

    PubMed 27447862

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 0 inclusion and 30 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 3 Nov 2016. 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?

Short Form Physical Performance Battery (SPPB) (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01644279, which also lists 5 linked publications.

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 3 Nov 2016.

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