An interventional study of Muscle Biopsy in Sarcopenia, Frailty and Aging, sponsored by National Institute on Aging (NIA). Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by National Institute on Aging (NIA) · Not applicable, Interventional, and Other
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:
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
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.
1,240 studies on the registry are indexed under Sarcopenia; 405 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 793 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →National Institute on Aging (NIA) is the lead sponsor of 160 studies on the registry; 13 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Performing muscle biopsies
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute on Aging (NIA) →