Nctid:
NCT00001624
Payload:
{"FullStudy"=>{"Rank"=>472870, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"November 27, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000006946", "ConditionMeshTerm"=>"Hyperinsulinism"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000044882", "ConditionAncestorTerm"=>"Glucose Metabolism Disorders"}, {"ConditionAncestorId"=>"D000008659", "ConditionAncestorTerm"=>"Metabolic Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9687", "ConditionBrowseLeafName"=>"Hyperinsulinism", "ConditionBrowseLeafAsFound"=>"Hyperinsulinemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M11329", "ConditionBrowseLeafName"=>"Metabolic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M25093", "ConditionBrowseLeafName"=>"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Nutritional and Metabolic Diseases", "ConditionBrowseBranchAbbrev"=>"BC18"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000007328", "InterventionMeshTerm"=>"Insulin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000007004", "InterventionAncestorTerm"=>"Hypoglycemic Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M10055", "InterventionBrowseLeafName"=>"Insulin", "InterventionBrowseLeafAsFound"=>"Was", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M173072", "InterventionBrowseLeafName"=>"Insulin, Globin Zinc", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M255659", "InterventionBrowseLeafName"=>"cyclo(Trp-Asp-Pro-Val-Leu)", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9744", "InterventionBrowseLeafName"=>"Hypoglycemic Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Hypoglycemic Agents", "InterventionBrowseBranchAbbrev"=>"Hypo"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antihypertensive Agents", "InterventionBrowseBranchAbbrev"=>"AnAg"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"16"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"March 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"February 1999", "CompletionDateStruct"=>{"CompletionDate"=>"March 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"=>["BQ-123", "Endothelin", "Insulin", "Plethysmography", "Vasoconstriction", "Healthy Volunteer"]}, "ConditionList"=>{"Condition"=>["Hyperinsulinemia"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"7916401", "ReferenceType"=>"background", "ReferenceCitation"=>"Haynes WG, Webb DJ. Contribution of endogenous generation of endothelin-1 to basal vascular tone. Lancet. 1994 Sep 24;344(8926):852-4. doi: 10.1016/s0140-6736(94)92827-4."}, {"ReferencePMID"=>"7788903", "ReferenceType"=>"background", "ReferenceCitation"=>"Donckier J, Stoleru L, Hayashida W, Van Mechelen H, Selvais P, Galanti L, Clozel JP, Ketelslegers JM, Pouleur H. Role of endogenous endothelin-1 in experimental renal hypertension in dogs. Circulation. 1995 Jul 1;92(1):106-13. doi: 10.1161/01.cir.92.1.106."}]}}, "DescriptionModule"=>{"BriefSummary"=>"Previous studies have shown that insulin may stimulate the release of endothelin (ET) from endothelial cells. This mechanism may contribute to the adverse vascular effects determined by chronic hyperinsulinemia. The aim of this study will be to evaluate the effect of local hyperinsulinemia on ET activity in the forearm circulation. To this purpose, we will assess the forearm blood flow response to ET receptor antagonism in control conditions and during intraarterial infusion of insulin. We will also measure changes in plasma ET-1 levels in response to the different pharmacological stimuli.", "DetailedDescription"=>"Previous studies have shown that insulin may stimulate the release of endothelin (ET) from endothelial cells. This mechanism may contribute to the adverse vascular effects determined by chronic hyperinsulinemia. The aim of this study will be to evaluate the effect of local hyperinsulinemia on ET activity in the forearm circulation. To this purpose, we will assess the forearm blood flow response to ET receptor antagonism in control conditions and during intraarterial infusion of insulin. We will also measure changes in plasma ET-1 levels in response to the different pharmacological stimuli."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers", "EligibilityCriteria"=>"Between 40-65 years old.\n\nNo medications.\n\nNo medical problems.\n\nNo serum cholesterol levels below 200 mg/dl.\n\nNo contraceptives."}, "IdentificationModule"=>{"NCTId"=>"NCT00001624", "BriefTitle"=>"Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation", "OrgStudyIdInfo"=>{"OrgStudyId"=>"970100"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"97-H-0100"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Insulin", "InterventionType"=>"Drug"}]}}, "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"}}}}}}
