Study of the Effects of Temperature on Metabolism in Human Muscle - Tabular View

Tracking Information
First Received Date ^ICMJE	November 3, 1999
Last Updated Date	March 3, 2008
Start Date ^ICMJE	September 1998
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00001753 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of the Effects of Temperature on Metabolism in Human Muscle
Official Title ^ICMJE	Study of Temperature Effects on Skeletal Muscle Aerobic Energy Metabolism
Brief Summary	This study will examine the role of temperature in changing energy metabolism in human muscle. In order to do this, researchers will use magnetic resonance imaging (MRI) to provide information about how parts of muscle operate during exercise. Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). In this study, MRI will be used to measure the temperature and energy level of specific muscles during rest and exercise. In addition, the muscles being tested will be heated and cooled to see if temperature directly affects levels of energy in muscle.
Detailed Description	This study will examine the role of temperature in modulating aspects of energy metabolism in human skeletal muscle. Tests will be conducted at rest and during concentric dorsiflexion exercise of the Tibialis anterior (TA) muscle using an existing custom-designed dynamometer in conjunction with mild local heating and cooling. Magnetic resonance spectroscopy (MRS), performed in a 4-tesla whole-body NMR system, will be used to non-invasively measure muscle temperature and energy-state. Specifically these tests will assess the extent to which temperature changes occur during aerobic exercise and how small temperature changes affect mitochondrial function in-vivo.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Procedure: Magnetic resonance imaging
Study Arms / Comparison Groups
Publications *	Fowler MD, Ryschon TW, Wysong RE, Combs CA, Balaban RS. Normalized metabolic stress for 31P-MR spectroscopy studies of human skeletal muscle: MVC vs. muscle volume. J Appl Physiol. 1997 Sep;83(3):875-83.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	17
Completion Date	November 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	Ages 18 to 50. Male and female subjects. Capable of giving informed consent. Healthy normal volunteers. No cardiac pacemaker of implantable defibrillator. No aneurysm clip. No neural stimulator (e.g. TENS-unit). No ear implant of any type. No metal in the eye (e.g. from machining). No implanted device (e.g. insulin pump, drug infusion device). No metallic foreign body, shrapnel, or bullet.
Gender	Both
Ages
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00001753
Responsible Party
Study ID Numbers ^ICMJE	980166, 98-H-0166
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	August 1999
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP