SarcopeniaTWEAKNCT02839460
A Prospective Study Of Biomarkers Of Skeletal Muscle Atrophy
An observational study of Sarcopenia, run by University of Florida at 1 site in United States.
Trial summary
This is a single center, prospective biomarker study to evaluate serum levels of TWEAK and expression levels of TWEAK and Fn14 in muscle biopsies from patients with sarcopenia as well as healthy, physically active controls. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Outpatient Muscle Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Mar 2019
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Subjects over age 65 Subjects with Sarcopenia Subjects who are healthy, physically-active controls
Who may be able to join
- To be eligible to participate in this study, all candidates must meet the following eligibility criteria at Baseline or at the time point specified in the individual eligibility criterion listed:
- All Participants
- 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
- Subjects with Sarcopenia
- Men and postmenopausal women of 65 years of age or older
- Gait speed measured over 4 meters of <1.0 m/s OR grip strength < 26 kg for men or < 16 kg for women.
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- Appendicular skeletal muscle adjusted for BMI by DXA ≤ 0.789 for men and ≤ 0.512 for women.
- Weigh at least 40kg;
- Self-reported difficulty climbing 10 steps OR walking outside on level ground for 1/4 mile
- Healthy Controls
- Men and postmenopausal women of 65 Years of age or older
- Body mass index (BMI) between 18.5 and 30 kg/m2 inclusive at the time of Screening
- Measures of Physical Performance and Lean Mass exceed thresholds defined for Sarcopenia group.
- ≥ 150 minutes/week moderate-intensity physical activity OR regular engagement in resistance training ≥ 2 days/week
- Willing to maintain a consistent diet and pattern of physical activity for the duration of the study
Who cannot join
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at Screening:
- History of human immunodeficiency virus (HIV), hepatitis B or C, or tuberculosis (TB)
- Immunocompromized subjects, as determined by the Investigator, based on medical history, physical examination, or laboratory testing, or due to prior or current immunosuppressive or immunomodulating treatment, including, but not limited to, HIV infection, history of organ transplantation, and anti-rejection therapy
- Acute infection (urinary, respiratory, other) within past week or hospitalization within one month
- Participation in any interventional clinical study within 12 weeks
- A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (e.g. stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip);
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- Any underlying muscle disease including active myopathy or muscular dystrophy.
- Confirmed diagnosis of heart failure classified as New York Heart Association Class III and IV (e.g. cardiomyopathy) or hypertrophic cardiomyopathy.
- Type I diabetes or uncontrolled Type 2 diabetes (HA1C ≥ 9).
- Requires regular assistance from another person for general activities of daily living (e.g. bathing, dressing)
- Moderate to Vigorous Exercise performed in week prior to study visits (temporary exclusion - will be rescheduled)
- Any other condition judged by the Principal Investigator or Study Physician to preclude safe participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Institute on Aging
Gainesville, Florida, 32611
About this study
Official title: A Single-Center, Prospective Study to Evaluate Biomarkers of Skeletal Muscle Atrophy in Sarcopenia
This is a single center, prospective biomarker study to evaluate serum levels of TWEAK and expression levels of TWEAK and Fn14 in muscle biopsies from patients with sarcopenia as well as healthy, physically active controls.
- Conditions
- Sarcopenia
- Being tested
- Outpatient Muscle Biopsy
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient Muscle BiopsyProcedure or surgery
Outpatient Muscle Biopsy involving skeletal muscle sample collected from the vastus lateralis muscle
| Study group | Role | What they receive |
|---|---|---|
| subjects with sarcopenia | Screening Procedures (Physical Exam, Height \& Weight, Vitals, Medical History, CHAMPS, DXA Scan, Physical Performance Testing, Muscle Strength Testing, Blood Collection)
Day 1 (target +/- 2 days) Outpatient Muscle Biopsy (Vitals, Blood Collection, Muscle Biopsy, update Concomitant Therapy and Procedure-Related AEs/SAEs)
Day 14 (target +/- 2 days) Safety Follow-up Visit (Vitals, Blood Collection, update Concomitant Therapy and Procedure-Related AEs/SAEs) Receives: Procedure: Outpatient Muscle Biopsy | |
| healthy, physically-active controls | Screening Procedures (Physical Exam, Height \& Weight, Vitals, Medical History, CHAMPS, DXA Scan, Physical Performance Testing, Muscle Strength Testing, Blood Collection)
Day 1 (target +/- 2 days) Outpatient Muscle Biopsy (Vitals, Blood Collection, Muscle Biopsy, update Concomitant Therapy and Procedure-Related AEs/SAEs)
Day 14 (target +/- 2 days) Safety Follow-up Visit (Vitals, Blood Collection, update Concomitant Therapy and Procedure-Related AEs/SAEs) Receives: Procedure: Outpatient Muscle Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of TWEAK at day 1
Measured: Day 1
Secondary outcomes (4)
Relative expression levels of TWEAK mRNA in muscle biopsy at day 1
Measured: Day 1
Relative expression levels of Fn14 mRNA in muscle biopsy at day 1
Measured: Day 1
Correlation between serum TWEAK levels and muscle strength
Measured: Day 1
Incidence of AEs and SAEs
Measured: Screening through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018
- Study completionMar 2019
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Sponsor
- Investigators
- Stephen D Anton, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839460
- Sponsor's protocol ID
- TWEAK
- Acronym
- TWEAK
- Status last verified
- Apr 2019
- First submitted
- 18 Jul 2016
- Last updated
- 11 Apr 2019
- 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 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective Study to Evaluate Biomarkers of Skeletal Muscle Atrophy in Sarcopenia
- ClinicalTrials.gov ID
- NCT02839460
- Acronym / sponsor ID
- TWEAK / TWEAK
- Conditions
- Sarcopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Nov 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 21 Jul 2016 (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.
This is a single center, prospective biomarker study to evaluate serum levels of TWEAK and expression levels of TWEAK and Fn14 in muscle biopsies from patients with sarcopenia as well as healthy, physically active controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects with sarcopenia | – | Procedure: Outpatient Muscle BiopsyScreening Procedures (Physical Exam, Height \& Weight, Vitals, Medical History, CHAMPS, DXA Scan, Physical Performance Testing, Muscle Strength Testing, Blood Collection) Day 1 (target +/- 2 days) Outpatient Muscle Biopsy (Vitals, Blood Collection, Muscle Biopsy, update Concomitant Therapy and Procedure-Related AEs/SAEs) Day 14 (target +/- 2 days) Safety Follow-up Visit (Vitals, Blood Collection, update Concomitant Therapy and Procedure-Related AEs/SAEs) |
| healthy, physically-active controls | – | Procedure: Outpatient Muscle BiopsyScreening Procedures (Physical Exam, Height \& Weight, Vitals, Medical History, CHAMPS, DXA Scan, Physical Performance Testing, Muscle Strength Testing, Blood Collection) Day 1 (target +/- 2 days) Outpatient Muscle Biopsy (Vitals, Blood Collection, Muscle Biopsy, update Concomitant Therapy and Procedure-Related AEs/SAEs) Day 14 (target +/- 2 days) Safety Follow-up Visit (Vitals, Blood Collection, update Concomitant Therapy and Procedure-Related AEs/SAEs) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Subjects over age 65 Subjects with Sarcopenia Subjects who are healthy, physically-active controls
Key inclusion criteria (15 listed)
- To be eligible to participate in this study, all candidates must meet the following eligibility criteria at Baseline or at the time point specified in the individual eligibility criterion listed:
- All Participants
- 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
- Subjects with Sarcopenia
- Men and postmenopausal women of 65 years of age or older
Key exclusion criteria (12 listed)
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at Screening:
- History of human immunodeficiency virus (HIV), hepatitis B or C, or tuberculosis (TB)
- Immunocompromized subjects, as determined by the Investigator, based on medical history, physical examination, or laboratory testing, or due to prior or current immunosuppressive or immunomodulating treatment, including, but not limited to, HIV infection, history of organ transplantation, and anti-rejection therapy
- Acute infection (urinary, respiratory, other) within past week or hospitalization within one month
- Participation in any interventional clinical study within 12 weeks
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 |
|---|---|---|
| Outpatient Muscle BiopsyOutpatient Muscle Biopsy involving skeletal muscle sample collected from the vastus lateralis muscle | Procedure or surgery | healthy, physically-active controls, subjects with sarcopenia |
Primary outcome
Serum concentration of TWEAK at day 1
Time frame: Day 1
4 secondary outcomes
Relative expression levels of TWEAK mRNA in muscle biopsy at day 1
Time frame: Day 1
Relative expression levels of Fn14 mRNA in muscle biopsy at day 1
Time frame: Day 1
Correlation between serum TWEAK levels and muscle strength
Time frame: Day 1
Incidence of AEs and SAEs
Time frame: Screening through Day 14
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 11 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Stephen D Anton, 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 15 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: finished, as of the sponsor's last update on 11 Apr 2019. 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?
Serum concentration of TWEAK at day 1 (time frame: Day 1). 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 11 Apr 2019.