A Prospective Study Of Biomarkers Of Skeletal Muscle Atrophy

NCT02839460 | Completed

• 1 other identifier: TWEAK
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Serum concentration of TWEAK at day 1

  Day 1

Secondary Outcomes (4)

• Relative expression levels of TWEAK mRNA in muscle biopsy at day 1

  Day 1

• Relative expression levels of Fn14 mRNA in muscle biopsy at day 1

  Day 1

• Correlation between serum TWEAK levels and muscle strength

  Day 1

• Incidence of AEs and SAEs

  Screening through Day 14

Study Arms (2)

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)

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)

Procedure: Outpatient Muscle Biopsy

Interventions

Outpatient Muscle Biopsy PROCEDURE

Outpatient Muscle Biopsy involving skeletal muscle sample collected from the vastus lateralis muscle

healthy, physically-active controls; subjects with sarcopenia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects over age 65 Subjects with Sarcopenia Subjects who are healthy, physically-active controls

You may qualify if:

• 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
• \. 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.
• 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

You may not qualify if:

• 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);
• 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)
• Any other condition judged by the Principal Investigator or Study Physician to preclude safe participation in the study

Sponsors & Collaborators

• University of Florida: lead
• Biogen: collaborator

Study Sites (1)

University of Florida Institute on Aging

Gainesville, Florida, 32611, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Muscle biopsy samples may be retained for mRNA analysis

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Stephen D Anton, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 21, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)