Muscle Biopsies in Healthy Volunteers

NCT01431677 | Terminated

• 2 other identifiers: 99991022110-AG-N221
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Frailty; Aging

Keywords

Muscle; Biopsy; Energetics; Sarcopenia; Frailty

Outcome Measures

Primary Outcomes (1)

• Performing muscle biopsies

Interventions

Muscle Biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

National Institute of Aging, Clinical Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• Bandeen-Roche K, Xue QL, Ferrucci L, Walston J, Guralnik JM, Chaves P, Zeger SL, Fried LP. Phenotype of frailty: characterization in the women's health and aging studies. J Gerontol A Biol Sci Med Sci. 2006 Mar;61(3):262-6. doi: 10.1093/gerona/61.3.262.

  PMID: 16567375 BACKGROUND

• Baur JA, Pearson KJ, Price NL, Jamieson HA, Lerin C, Kalra A, Prabhu VV, Allard JS, Lopez-Lluch G, Lewis K, Pistell PJ, Poosala S, Becker KG, Boss O, Gwinn D, Wang M, Ramaswamy S, Fishbein KW, Spencer RG, Lakatta EG, Le Couteur D, Shaw RJ, Navas P, Puigserver P, Ingram DK, de Cabo R, Sinclair DA. Resveratrol improves health and survival of mice on a high-calorie diet. Nature. 2006 Nov 16;444(7117):337-42. doi: 10.1038/nature05354. Epub 2006 Nov 1.

  PMID: 17086191 BACKGROUND

• Civitarese AE, Ukropcova B, Carling S, Hulver M, DeFronzo RA, Mandarino L, Ravussin E, Smith SR. Role of adiponectin in human skeletal muscle bioenergetics. Cell Metab. 2006 Jul;4(1):75-87. doi: 10.1016/j.cmet.2006.05.002.

  PMID: 16814734 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Josephine M Egan, M.D.

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 9, 2011
• Study Start: May 17, 2010
• Primary Completion: June 16, 2014
• Study Completion: July 29, 2014
• Last Updated: December 17, 2019

Record last verified: 2014-07-29

Locations

US (1)