Muscle Biopsies in Healthy Volunteers

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT01431677
First received: September 8, 2011
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.

Condition Intervention
Sarcopenia
Frailty
Aging
Procedure: Muscle Biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Muscle Biopsies in Healthy Volunteers: a Pilot Study

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Performing muscle biopsies

Estimated Enrollment: 200
Study Start Date: May 2010
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Muscle Biopsy
    N/A
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431677

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

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT01431677     History of Changes
Other Study ID Numbers: 999910221, 10-AG-N221
Study First Received: September 8, 2011
Last Updated: July 31, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Muscle
Biopsy
Energetics
Sarcopenia
Frailty

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

ClinicalTrials.gov processed this record on October 19, 2014