NCT02116166

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

2.2 years

First QC Date

April 14, 2014

Last Update Submit

April 4, 2018

Conditions

Keywords

agingsarcopeniamitochondriaskeletal muscleinflammation

Outcome Measures

Primary Outcomes (14)

  • Tumor Necrosis Factor alpha (TNF-alpha)

    Inflammation marker; measured in muscle biopsy specimens.

    baseline

  • tumor-necrosis factor receptor-1 (TNFR1)

    Inflammation marker; measured in muscle biopsy specimens.

    baseline

  • Phospho-Inhibitory Subunit Of NF-KBα (pIkBα)

    Inflammation marker; measured in muscle biopsy specimens.

    baseline

  • Chemokine (C-C motif) ligand 2 (CCL2)

    Inflammation marker; measured in muscle biopsy specimens.

    baseline

  • zinc transporter (ZIP) 14

    Inflammation marker; measured in muscle biopsy specimens.

    baseline

  • Interleukin 6 (IL-6)

    Inflammation marker; measured in muscle biopsy specimens.

    baseline

  • Interleukin (IL) 11β

    Inflammation marker; measured in muscle biopsy specimens.

    baseline

  • Interleukin 8 (IL-8)

    Inflammation marker; measured in muscle biopsy specimens.

    baseline

  • C-C chemokine receptor type 2 (CCR2)

    Inflammation marker; measured in muscle biopsy specimens.

    baseline

  • zinc transporter 14 (ZIP14)

    Inflammation marker; measured in muscle biopsy specimens.

    baseline

  • copper

    metals; measured in muscle biopsy specimens.

    baseline

  • zinc

    metals; measured in muscle biopsy specimens.

    baseline

  • iron

    metals; measured in muscle biopsy specimens.

    baseline

  • ribosome profiling

    DNA damage on pattern and dynamics of mRNA translation in human muscle tissue; measured in muscle biopsy specimens.

    baseline

Study Arms (2)

Young

Young (20-35 years old)

Old

Older (70-99 years old)

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young (age 20-35 years; N =10)

You may qualify if:

  • males and females aged 20-35.
  • willing and able to give informed consent.

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Skeletal muscle biopsy

MeSH Terms

Conditions

SarcopeniaInflammation

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPathologic Processes

Study Officials

  • Christiaan Leeuwenburgh, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 16, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations