Muscle Biopsies in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431677
Recruitment Status : Terminated
First Posted : September 9, 2011
Last Update Posted : June 20, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )

Brief Summary:


- 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.


  • 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.


- Healthy volunteers at least 18 years of age.


  • 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.

Condition or disease Intervention/treatment Phase
Sarcopenia Frailty Aging Procedure: Muscle Biopsy Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Muscle Biopsies in Healthy Volunteers: a Pilot Study
Study Start Date : May 17, 2010
Actual Primary Completion Date : June 16, 2014
Actual Study Completion Date : July 29, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Primary Outcome Measures :
  1. Performing muscle biopsies

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01431677

United States, Maryland
National Institute of Aging, Clinical Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: Josephine M Egan, M.D. National Institute on Aging (NIA)

Responsible Party: National Institute on Aging (NIA) Identifier: NCT01431677     History of Changes
Other Study ID Numbers: 999910221
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: July 29, 2014

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) ):

Additional relevant MeSH terms:
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Signs and Symptoms