Muscle Biopsies in Healthy Volunteers
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | May 17, 2010 |
| End Date: | July 29, 2014 |
Muscle Biopsies in Healthy Volunteers: a Pilot Study
Background:
- In individuals as they age, changes in muscle tissue can significantly affect their muscle
strength and exercise endurance. This process, known as sarcopenia, may lead to decreased
mobility and physical weakness, which is what we in general refer to as frailty. The causes
of sarcopenia and why it affects some individuals more than others are not known, but many
factors influence muscle physiology and function, including metabolic, hormonal,
environmental, and lifestyle factors. Researchers interested in identifying factors involved
in the start and progression of sarcopenia need of samples of human muscle tissue and cells
for laboratory investigations.
Objectives:
- To train researchers in the appropriate procedures for performing muscle biopsies and
collecting, labeling, and storing the samples.
- Develop a data base of specific scientific studies evaluating the physiological and
metabolic function of muscle that can be used in future studies.
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a full medical history and physical examination, as
well as blood and urine tests, and will schedule a date for the muscle biopsy.
- Participants will have a muscle biopsy, with tissue and cells taken from the upper part
of the thigh. A local anesthetic will be given for the procedure. Participants will also
provide a blood sample and have an electrocardiogram to evaluate heart function.
- Participants will have a followup visit 1 week after the biopsy visit to evaluate the
healing process and provide any further treatment for the affected area, after which
they may fully resume normal activities.
- In individuals as they age, changes in muscle tissue can significantly affect their muscle
strength and exercise endurance. This process, known as sarcopenia, may lead to decreased
mobility and physical weakness, which is what we in general refer to as frailty. The causes
of sarcopenia and why it affects some individuals more than others are not known, but many
factors influence muscle physiology and function, including metabolic, hormonal,
environmental, and lifestyle factors. Researchers interested in identifying factors involved
in the start and progression of sarcopenia need of samples of human muscle tissue and cells
for laboratory investigations.
Objectives:
- To train researchers in the appropriate procedures for performing muscle biopsies and
collecting, labeling, and storing the samples.
- Develop a data base of specific scientific studies evaluating the physiological and
metabolic function of muscle that can be used in future studies.
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a full medical history and physical examination, as
well as blood and urine tests, and will schedule a date for the muscle biopsy.
- Participants will have a muscle biopsy, with tissue and cells taken from the upper part
of the thigh. A local anesthetic will be given for the procedure. Participants will also
provide a blood sample and have an electrocardiogram to evaluate heart function.
- Participants will have a followup visit 1 week after the biopsy visit to evaluate the
healing process and provide any further treatment for the affected area, after which
they may fully resume normal activities.
An important concept in pathologic aging is that in some individuals muscle strength and
exercise endurance are significantly decreased through both quantitative and qualitative
changes in muscle tissue. This process, termed sarcopenia, leads to frailty, a syndrome
characterized by decreased mobility, weakness, and a very poor prognosis for survival,
although the causal pathway for this association is not known. The causes of sarcopenia and
why it affects some individuals more than others is not known. This is a complicated
scientific question because many factors influence muscle physiology and function, including
metabolic, hormonal, environmental, life-style, co-morbid medical problems and their
treatments, etc. The National Institute on Aging (NIA) has a long-standing interest in
sarcopenia and frailty and has established a number of observational studies aimed at
understanding the cause and course of these age-related conditions. It is our goal to try to
identify factors involved in the initiation and progression of sarcopenia and frailty, and to
develop therapies that can reverse or slow these processes. To identify molecular and genetic
changes that are associated with sarcopenia, it is crucial that human muscle biopsy specimens
be available for laboratory investigations. This proposal will enable the Clinical Research
Branch (CRB) to set up this procedure on the NIA Clinical Research Unit located on the fifth
floor at Harbor Hospital, and to hone the practical skills that will be needed for analyzing
muscle tissue from individuals in observational and interventional clinical trials. The goal
will be to become facile at performing muscle biopsies, collecting, labeling and storing the
samples, and to ensure that all equipment and expertise required to efficiently perform the
procedure are in place. 14 healthy volunteers will be accrued to the study, however after
this, the protocol will be kept open for the purpose of training other physicians or nurse
practitioners in the biopsy procedure.
exercise endurance are significantly decreased through both quantitative and qualitative
changes in muscle tissue. This process, termed sarcopenia, leads to frailty, a syndrome
characterized by decreased mobility, weakness, and a very poor prognosis for survival,
although the causal pathway for this association is not known. The causes of sarcopenia and
why it affects some individuals more than others is not known. This is a complicated
scientific question because many factors influence muscle physiology and function, including
metabolic, hormonal, environmental, life-style, co-morbid medical problems and their
treatments, etc. The National Institute on Aging (NIA) has a long-standing interest in
sarcopenia and frailty and has established a number of observational studies aimed at
understanding the cause and course of these age-related conditions. It is our goal to try to
identify factors involved in the initiation and progression of sarcopenia and frailty, and to
develop therapies that can reverse or slow these processes. To identify molecular and genetic
changes that are associated with sarcopenia, it is crucial that human muscle biopsy specimens
be available for laboratory investigations. This proposal will enable the Clinical Research
Branch (CRB) to set up this procedure on the NIA Clinical Research Unit located on the fifth
floor at Harbor Hospital, and to hone the practical skills that will be needed for analyzing
muscle tissue from individuals in observational and interventional clinical trials. The goal
will be to become facile at performing muscle biopsies, collecting, labeling and storing the
samples, and to ensure that all equipment and expertise required to efficiently perform the
procedure are in place. 14 healthy volunteers will be accrued to the study, however after
this, the protocol will be kept open for the purpose of training other physicians or nurse
practitioners in the biopsy procedure.
- INCLUSION CRITERIA:
Healthy volunteers over the age of 18
Normal screening laboratory studies including CBC, chem. 12 panel, PT/PTT, INR, UA, EKG
Ability to provide informed consent
EXCLUSION CRITERIA:
No history of bleeding diathesis
Subject is not on heparin, coumadin, plavix, or other anticoagulant
Subjects taking aspirin or non-steroidal anti-inflammatory agents must stop these 7 days
before the biopsy
No allergy to lidocaine or bupivacaine
Subject has no active infections or chronic skin conditions that prevent access to the
biopsy area
Unable to provide informed consent
No antibiotics for the past week
Positive pregnancy test
Positive for HIV, and/or positive for hepatitis B or C
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