Blood Flow, Muscle Regeneration and Sarcopenia

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01035060
First received: December 17, 2009
Last updated: December 4, 2012
Last verified: October 2012
  Purpose

Due to the rapid aging of the population, sarcopenia is among the greatest challenges facing the health care system over the next quarter century. This age-related loss of skeletal muscle mass and strength directly contributes to the incidence of functional disability, thereby reducing independence and quality of life for the elderly. Despite increasing efforts to combat sarcopenia, its etiology remains incompletely described. Subsequently, limited progress has been made in developing comprehensive preventative and therapeutic strategies to combat the problem. A decreased ability to regenerate skeletal muscle fibers through the donation of skeletal muscle stem cells (satellite cells) is thought to contribute to sarcopenia. However, the upstream physiological mediators that regulate this impairment are poorly delineated.

Reduced muscle blood flow in advanced age appears to be a significant factor in reducing skeletal muscle regenerative capacity, but few data exist to confirm this hypothesis. Thus to test this hypothesis we aim to conduct a translational pilot trial which examines regeneration in both young and old adults. Furthermore, we aim to determine if muscle blood flow and satellite cell number are associated with muscle function. The central hypothesis of this proposal is that age-related declines in skeletal muscle angiogenesis and perfusion are significant causal factors in age-related losses of skeletal muscle mass. The specific aims and hypotheses of the project are as follows:


Condition
Sarcopenia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Role of Skeletal Muscle Blood in Muscle Regeneration and Sarcopenia

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Muscle Satellite Cells [ Time Frame: Baseline, 2 days post-injury, 7 days post-injury ] [ Designated as safety issue: No ]
    Change in the number of myonuclear cells identified as Pax7+ following contraction-induced skeletal muscle injury. Cells identified as Pax7+ by immunohistochemistry of skeletal muscle biopsy samples. Data adjusted for gender, physical activity level, and baseline satellite cell number.


Biospecimen Retention:   Samples Without DNA

Serum/Plasma; Skeletal Muscle; Adipose Tissue


Enrollment: 68
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Older Adult
Healthy Men and Women Over 70 Years of Age
Young Adult
Healthy Men and Women Aged 18-30 Years

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community Sample

Criteria

Inclusion Criteria:

  • Men and women aged 18-30 years
  • Men and women aged > 70 years
  • Body mass index < 35
  • Willing and able to participate in all aspects of the study
  • Sedentary to moderately active lifestyle <120 min physical activity/week < 30 min moderate aerobic exercise/week < 30 min resistance training/week OR Participates in regular structured exercise > 120 min/week
  • Non-smoking

Exclusion Criteria:

  • Active treatment for cancer, stroke (< 6 mo), peripheral vascular disease, coronary artery disease (myocardial infarction <6 mo), state III, IV Congestive Heart Failure, valvular heart disease, major psychiatric disease, severe anemia, liver or renal disease, diabetes, severe osteoarthritis, blindness or deafness, fracture in upper or lower extremity within the last 6 months, upper or lower extremity amputation, anticoagulant therapy (aspirin use is permitted), parkinsons disease
  • Failure to give consent
  • Anabolic medications (growth hormone or testosterone)
  • High amounts of physical activity (i.e. running, bicycling etc > 120 min/week).
  • Dementing illness
  • Smoking
  • Pregnant
  • Significant cognitive impairment; Mini-Mental State (MMSE) exam < 24
  • Statin Usage
  • Excessive alcohol use (>2 drinks per day)
  • Resting heart rate > 120 bpm
  • Systolic blood pressure > 180 mmHg
  • Diastolic blood pressure > 110 mmHg
  • History of significant head injury
  • Anticholinesterase inhibitor (such as Aricept)
  • Contraindications to MRI (e.g. cardiac pacemaker, implanted cardiac defibrillator, aneurysm clip, claustrophobia, etc.)
  • Current Use of Antidepressant Medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01035060

Locations
United States, Florida
Aging and Rehabilitation Research Center
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Thomas W. Buford, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01035060     History of Changes
Other Study ID Numbers: 37268
Study First Received: December 17, 2009
Results First Received: December 4, 2012
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014