Study of the Effects of Temperature on Metabolism in Human Muscle

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Dec 9, 2002

Nctid: NCT00001753

Payload: {"FullStudy"=>{"Rank"=>473978, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M11600", "ConditionBrowseLeafName"=>"Mitral Valve Insufficiency", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"17"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"September 1998"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"August 1999", "CompletionDateStruct"=>{"CompletionDate"=>"November 2000"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Exercise", "MRI", "MRS", "Normal Volunteer", "Tibialix Anterior"]}, "ConditionList"=>{"Condition"=>["Healthy"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"9292476", "ReferenceType"=>"background", "ReferenceCitation"=>"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 (1985). 1997 Sep;83(3):875-83. doi: 10.1152/jappl.1997.83.3.875."}]}}, "DescriptionModule"=>{"BriefSummary"=>"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.\n\nMagnetic 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.", "DetailedDescription"=>"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."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Ages 18 to 50.\n\nMale and female subjects.\n\nCapable of giving informed consent.\n\nHealthy normal volunteers.\n\nNo cardiac pacemaker of implantable defibrillator.\n\nNo aneurysm clip.\n\nNo neural stimulator (e.g. TENS-unit).\n\nNo ear implant of any type.\n\nNo metal in the eye (e.g. from machining).\n\nNo implanted device (e.g. insulin pump, drug infusion device).\n\nNo metallic foreign body, shrapnel, or bullet."}, "IdentificationModule"=>{"NCTId"=>"NCT00001753", "BriefTitle"=>"Study of the Effects of Temperature on Metabolism in Human Muscle", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Study of Temperature Effects on Skeletal Muscle Aerobic Energy Metabolism", "OrgStudyIdInfo"=>{"OrgStudyId"=>"980166"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"98-H-0166"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Magnetic resonance imaging", "InterventionType"=>"Procedure"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Heart, Lung and Blood Institute (NHLBI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}