Nctid:
NCT00001276
Payload:
{"FullStudy"=>{"Rank"=>474362, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007340", "ConditionMeshTerm"=>"Insulinoma"}, {"ConditionMeshId"=>"D000007003", "ConditionMeshTerm"=>"Hypoglycemia"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000044882", "ConditionAncestorTerm"=>"Glucose Metabolism Disorders"}, {"ConditionAncestorId"=>"D000008659", "ConditionAncestorTerm"=>"Metabolic Diseases"}, {"ConditionAncestorId"=>"D000007516", "ConditionAncestorTerm"=>"Adenoma, Islet Cell"}, {"ConditionAncestorId"=>"D000000236", "ConditionAncestorTerm"=>"Adenoma"}, {"ConditionAncestorId"=>"D000009375", "ConditionAncestorTerm"=>"Neoplasms, Glandular and Epithelial"}, {"ConditionAncestorId"=>"D000009370", "ConditionAncestorTerm"=>"Neoplasms by Histologic Type"}, {"ConditionAncestorId"=>"D000009369", "ConditionAncestorTerm"=>"Neoplasms"}, {"ConditionAncestorId"=>"D000010190", "ConditionAncestorTerm"=>"Pancreatic Neoplasms"}, {"ConditionAncestorId"=>"D000004067", "ConditionAncestorTerm"=>"Digestive System Neoplasms"}, {"ConditionAncestorId"=>"D000009371", "ConditionAncestorTerm"=>"Neoplasms by Site"}, {"ConditionAncestorId"=>"D000004701", "ConditionAncestorTerm"=>"Endocrine Gland Neoplasms"}, {"ConditionAncestorId"=>"D000004066", "ConditionAncestorTerm"=>"Digestive System Diseases"}, {"ConditionAncestorId"=>"D000010182", "ConditionAncestorTerm"=>"Pancreatic Diseases"}, {"ConditionAncestorId"=>"D000004700", "ConditionAncestorTerm"=>"Endocrine System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9743", "ConditionBrowseLeafName"=>"Hypoglycemia", "ConditionBrowseLeafAsFound"=>"Hypoglycemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10065", "ConditionBrowseLeafName"=>"Insulinoma", "ConditionBrowseLeafAsFound"=>"Insulinoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M11329", "ConditionBrowseLeafName"=>"Metabolic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M25093", "ConditionBrowseLeafName"=>"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M3281", "ConditionBrowseLeafName"=>"Adenoma", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10238", "ConditionBrowseLeafName"=>"Adenoma, Islet Cell", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12010", "ConditionBrowseLeafName"=>"Neoplasms, Glandular and Epithelial", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12005", "ConditionBrowseLeafName"=>"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12800", "ConditionBrowseLeafName"=>"Pancreatic Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8576", "ConditionBrowseLeafName"=>"Gastrointestinal Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6946", "ConditionBrowseLeafName"=>"Digestive System Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7553", "ConditionBrowseLeafName"=>"Endocrine Gland Neoplasms", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8573", "ConditionBrowseLeafName"=>"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6945", "ConditionBrowseLeafName"=>"Digestive System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12792", "ConditionBrowseLeafName"=>"Pancreatic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M7552", "ConditionBrowseLeafName"=>"Endocrine System Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T3077", "ConditionBrowseLeafName"=>"Insulinoma", "ConditionBrowseLeafAsFound"=>"Insulinoma", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"T4387", "ConditionBrowseLeafName"=>"Pancreatic Cancer", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Nutritional and Metabolic Diseases", "ConditionBrowseBranchAbbrev"=>"BC18"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Neoplasms", "ConditionBrowseBranchAbbrev"=>"BC04"}, {"ConditionBrowseBranchName"=>"Digestive System Diseases", "ConditionBrowseBranchAbbrev"=>"BC06"}, {"ConditionBrowseBranchName"=>"Gland and Hormone Related Diseases", "ConditionBrowseBranchAbbrev"=>"BC19"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"StudyType"=>"Observational", "DesignInfo"=>{"DesignTimePerspectiveList"=>{"DesignTimePerspective"=>["Prospective"]}, "DesignObservationalModelList"=>{"DesignObservationalModel"=>["Cohort"]}}, "EnrollmentInfo"=>{"EnrollmentType"=>"Anticipated", "EnrollmentCount"=>"1500"}}, "StatusModule"=>{"OverallStatus"=>"Recruiting", "StartDateStruct"=>{"StartDate"=>"July 17, 1995", "StartDateType"=>"Actual"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"August 31, 2023", "LastUpdateSubmitDate"=>"November 23, 2023", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"November 3, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"November 27, 2023", "LastUpdatePostDateType"=>"Actual"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 4, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Treatment Outcomes", "PrimaryOutcomeTimeFrame"=>"every 1-3 months", "PrimaryOutcomeDescription"=>"resolution of hypoglycemia"}]}}, "OversightModule"=>{"IsFDARegulatedDrug"=>"No", "IsFDARegulatedDevice"=>"No"}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Hypoglycemia", "Insulinoma", "Natural History"]}, "ConditionList"=>{"Condition"=>["Hypoglycemia", "Insulinoma"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"194912", "ReferenceType"=>"background", "ReferenceCitation"=>"Bar RS, Gorden P, Roth J, Siebert CW. Insulin receptors in patients with insulinomas: changes in receptor affinity and concentration. J Clin Endocrinol Metab. 1977 Jun;44(6):1210-3. doi: 10.1210/jcem-44-6-1210."}, {"ReferencePMID"=>"6349454", "ReferenceType"=>"background", "ReferenceCitation"=>"Blackshear PJ, Rotner HE, Kriauciunas KA, Kahn CR. Reactive hypoglycemia and insulin autoantibodies in drug-induced lupus erythematosus. Ann Intern Med. 1983 Aug;99(2):182-4. doi: 10.7326/0003-4819-99-2-182."}, {"ReferencePMID"=>"3568598", "ReferenceType"=>"background", "ReferenceCitation"=>"Comi RJ, Gorden P. Approach to hypoglycemia in adults. Compr Ther. 1987 Mar;13(3):38-44. No abstract available."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1991-DK-0066.html", "SeeAlsoLinkLabel"=>"NIH Clinical Center Detailed Web Page"}]}}, "DescriptionModule"=>{"BriefSummary"=>"Hypoglycemia is the term used to refer to lower than normal levels of blood sugar. This study will continue to research the causes of hypoglycemia.\n\nPatients involved in the study will be admitted to the Clinical Center of the National Institutes of Health and undergo tests for evaluating blood sugar. Patients will be required to refrain from eating for a set period of time and will undergo blood tests for insulin levels and several other specific diagnostic tests related to insulin secretion. The patients will be under supervision and will be provided with appropriate medical and surgical attention as needed....", "DetailedDescription"=>"Study Description:\n\nThe purpose of this study is to gain knowledge and experience in the diagnosis and therapy of patients with fasting hypoglycemia due to diverse etiologies, such as insulinomas. Study subjects will be evaluated and treated for their particular condition according to standard care.\n\nObjectives:\n\nTo understand the pathophysiology and various causes of hypoglycemia (e.g., insulinomas, MEN1, MEN2).\nTo identify new circulating biomarkers of insulinomas.\nTo create a repository of clinical data and samples for future research of insulinomas.\n\nEndpoints: None"}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"120 years", "MinimumAge"=>"18 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "SamplingMethod"=>"Non-Probability Sample", "StudyPopulation"=>"Patients how are referred to us that have fasting hypoglycemia due to diverse etiologies.@@@@@@", "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nMale, females ages >= 18.\nPatients with documented fasting blood glucose below 55 mg/dl.\n\n4. Patients with biochemical evidence for insulinoma or other pancreatic neuroendocrine tumors.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nPatients with significant cardiac disease will be excluded.\nSubjects who are pregnant per self-report.\nMedically unstable per the assessment of the PI."}, "IdentificationModule"=>{"NCTId"=>"NCT00001276", "BriefTitle"=>"Diagnosing and Treating Low Blood Sugar Levels", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"Fasting Hypoglycemia: Diagnosis and Treatment", "OrgStudyIdInfo"=>{"OrgStudyId"=>"910066"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"91-DK-0066"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupLabel"=>"Patients with hypoglycemia", "ArmGroupDescription"=>"Patients with hypoglycemia due to diverse etiologies."}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationStatus"=>"Recruiting", "LocationCountry"=>"United States", "LocationFacility"=>"National Institutes of Health Clinical Center"}]}, "CentralContactList"=>{"CentralContact"=>[{"CentralContactName"=>"Craig S Cochran, R.N.", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"craigc@bdg10.niddk.nih.gov", "CentralContactPhone"=>"(301) 402-1880"}, {"CentralContactName"=>"Ranganath Muniyappa, M.D.", "CentralContactRole"=>"Contact", "CentralContactEMail"=>"muniyapr@mail.nih.gov", "CentralContactPhone"=>"(301) 451-7702"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Ranganath Muniyappa, M.D.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
