Blood Flow, Muscle Regeneration and Sarcopenia

NCT01035060 | Completed Results DMC

• 1 other identifier: 37268
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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:

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Muscle Satellite Cells

  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.

  Baseline, 2 days post-injury, 7 days post-injury

Study Arms (2)

Older Adult

Healthy Men and Women Over 70 Years of Age

Young Adult

Healthy Men and Women Aged 18-30 Years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community Sample

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Aging and Rehabilitation Research Center

Gainesville, Florida, 32611, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum/Plasma; Skeletal Muscle; Adipose Tissue

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

Results Point of Contact

• Title: Dr. Thomas Buford
• Organization: University of Florida

tbuford@ufl.edu

352-273-5918

Study Officials

• Thomas W. Buford, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 18, 2009
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 9, 2013
• Results First Posted: January 9, 2013

Record last verified: 2012-10

Locations

US (1)