Blood Flow, Muscle Regeneration and Sarcopenia

NCT ID: NCT01035060

Last Updated: 2013-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Older Adult

Healthy Men and Women Over 70 Years of Age

No interventions assigned to this group

Young Adult

Healthy Men and Women Aged 18-30 Years

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas W. Buford, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Aging and Rehabilitation Research Center

Gainesville, Florida, United States

Countries

United States

Other Identifiers

37268

Identifier Type: -

Identifier Source: org_study_id