Nctid:
NCT00001168
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M9988", "name"=>"Hypercholesterolemia", "relevance"=>"LOW"}, {"id"=>"M10000", "name"=>"Hyperlipidemias", "relevance"=>"LOW"}, {"id"=>"M10002", "name"=>"Hyperlipoproteinemias", "relevance"=>"LOW"}, {"id"=>"M10003", "name"=>"Hyperlipoproteinemia Type III", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>1017}}, "statusModule"=>{"overallStatus"=>"ACTIVE_NOT_RECRUITING", "startDateStruct"=>{"date"=>"1979-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-10-20", "lastUpdateSubmitDate"=>"2024-08-17", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2024-08-20", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"screening and evaluation of individuals with potential disorders of lipid metabolism in order to provide training for professional Lipid Service staff in the evaluation and treatment of patients with genetic dyslipoproteinemias.", "timeFrame"=>"six years", "description"=>"Eligible"}], "secondaryOutcomes"=>[{"measure"=>"Some of these patients may be candidates for enrollment in other Lipid Service research protocols.", "timeFrame"=>"six years", "description"=>"Some of these patients may be candidates for enrollment in other Lipid Service research protocols."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["High Cholesterol", "High HDL", "Low HDL", "LCAT Defiency", "Natural History", "Type III Hyperlipoproteinemia", "Plasma Lipoproteins"], "conditions"=>["Evaluation of Plasma Lipoproteins"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1979-H-0100.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"Lipoproteins are particles that carry fats such as cholesterol and triglycerides through the blood stream. These particles are involved in causing blood vessel disease that can lead to conditions like hardening of the arteries (atherosclerosis) or heart attacks (myocardial infarctions).\n\nThis study is designed to look closely at the factors affecting lipoproteins. Researchers plan to study patients and normal volunteers by measuring lipoprotein levels in the blood. Patients and volunteers will be placed on a balanced diet during the study. In addition, researchers plan to measure levels of various hormone and enzymes in the blood. Patients and volunteers participating in the study may be asked to undergo more specific tests in order to collect more information about lipoprotein metabolism.\n\nThis study may not provide direct benefits to patients and volunteers participating in it. However, information gathered from this study may help researchers develop better skills and techniques to diagnose and treat patients with diseases of lipoprotein metabolism.", "detailedDescription"=>"The lipoprotein transport system is vital to the delivery of the hydrophobic fats that are carried in the aqueous environment of the blood. The lipoprotein particles that comprise this system are polydisperse and contain triglycerides, free and esterified cholesterol, phospholipids and proteins. Inborn errors in the lipoprotein transport system lead to alterations in both the steady state concentrations of the various lipoproteins and in the metabolism of these particles. These inborn errors lead to both hyperlipoproteinemia and hypolipoproteinemia. Profound changes in the ambient lipoprotein concentrations have a variety of clinical manifestations. The present study protocol is designed to permit a full evaluation of the lipids, lipoproteins, and apolipoproteins, in patients with potential genetic defects in these processes. The protocol will also permit training of students, staff clinicians, physician assistants, nurse practitioners, dieticians and post-doctoral fellows in the evaluation and treatment of patients with dyslipidemias. The study population will include patients which are referred to the Lipid Service from private care providers, academic institutions, or the NHLBI Lipid website, with any of the following potential lipid abnormalities or clinical stigmata associated with dyslipoproteinemias: a) increased plasma levels of cholesterol, triglycerides, HDL-cholesterol or LDL-cholesterol b) decreased plasma concentrations of cholesterol and HDL-cholesterol c) postprandial hyperlipidemia or d) eruptive xanthomas, xanthelasma, tuberous or tendinous xanthomas, or corneal opacities."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "maximumAge"=>"99 years", "minimumAge"=>"2 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"unlimited", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n\nPlasma cholesterol levels greater than 200 mg/dl or less than 120 mg/dl - includes patients with diagnoses such as familial hypercholesterolemia, familial combined hyperlipidemia, sitosterolemia, cholesteryl ester storage disease, Erdheim chester disease, lipoprotein lipase, hepatic lipase or apo-CII deficiency, and dysbetalipoproteinemia.\n\nPlasma LDL-C levels greater than 130 mg/dl or less than 70 mg/dl - includes patients with diagnoses such as familial hypercholesterolemia, familial combined hyperlipidemia, lipoprotein lipase, hepatic lipase, or apo-CII deficiency, sitosterolemia, dysbetalipoproteinemia, abetalipoproteinemia and hypobetalipoproteinemia.\n\nPlasma HDL-C levels greater than 70 mg/dl or less than 25 mg/dl - includes patients with deficiency of cholesteryl ester transfer protein, lecithin cholesterol acyltransferase, phospholipid transfer protein, lipoprotein lipase, hepatic lipase, or apo-CII, and Tangier disease.\n\nPlasma triglyceride levels greater than 150 mg/dl - includes patients with deficiency of lipoprotein lipase, hepatic lipase or apoC-II, dysbetalipoproteinemia, Type IV and Type V hyperlipidemia.\n\nEXCLUSION CRITERIA:\n\nInability to provide informed consent."}, "identificationModule"=>{"nctId"=>"NCT00001168", "briefTitle"=>"Evaluation of Lipoproteins", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Teaching Protocol for the Evaluation of Plasma Lipoproteins", "orgStudyIdInfo"=>{"id"=>"790100"}, "secondaryIdInfos"=>[{"id"=>"79-H-0100"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Dyslipidemia", "description"=>"Dyslipidemia", "interventionNames"=>["Behavioral: Balanced diet"]}], "interventions"=>[{"name"=>"Balanced diet", "type"=>"BEHAVIORAL", "armGroupLabels"=>["Dyslipidemia"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institutes of Health Clinical Center", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "overallOfficials"=>[{"name"=>"Robert D Shamburek, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"National Heart, Lung, and Blood Institute (NHLBI)"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
