Blood Flow, Muscle Regeneration and Sarcopenia

Sarcopenia Clinical Trial

Official title:

Role of Skeletal Muscle Blood in Muscle Regeneration and Sarcopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035060
• Other study ID #: 37268
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: December 4, 2012
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Sarcopenia

Locations

Country	Name	City	State
United States	Aging and Rehabilitation Research Center	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, 2 days post-injury, 7 days post-injury	No