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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older Adult | Healthy Men and Women Over 70 Years of Age | ||
| Young Adult | Healthy Men and Women Aged 18-30 Years |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Community Sample
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| Name | Affiliation | Role |
|---|---|---|
| Thomas W. Buford, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aging and Rehabilitation Research Center | Gainesville | Florida | 32611 | United States |
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From September 2010 through December 2011, community-dwelling persons were recruited to participate through a variety of methods including media articles, direct mailings, newspaper announcements, and presentations to community groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Older Adults | Persons aged ≥ 70 years |
| FG001 | Young Adults | Persons aged 18-30 years |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Older Adults | |
| BG001 | Young Adults | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | Number of Pax7+ cells/muscle fiber | Baseline, 2 days post-injury, 7 days post-injury |
|
14 months
Data collected during study visits from September 2010 to December 2011
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Younger Adults |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment | Not as a result of the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skeletal Muscle Soreness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | In response to exercise bout |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Buford | University of Florida | 352-273-5918 | tbuford@ufl.edu |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Serum/Plasma; Skeletal Muscle; Adipose Tissue
| Withdrawal by Subject |
|
| Physician Decision |
|
Total of all reporting groups
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 29 |
| 6 |
| 29 |
| EG001 | Older Adults | 2 | 39 | 7 | 39 |
|
| Hospitalization | Blood and lymphatic system disorders | Non-systematic Assessment | Participant was hospitalized for blood clots in both legs |
|
|
| Pain/Bruising | General disorders | Non-systematic Assessment | Following muscle biopsy |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Unrelated to study procedures |
|
| Broken Toe | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Unrelated to study procedures |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Mild swelling | General disorders | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment | Unrelated to study procedures |
|
| Minor Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |