Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-01-09 @ 11:33 PM
Study NCT ID:
NCT02656095
Status:
COMPLETED
Last Update Posted:
2019-07-11
First Post:
2016-01-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008072', 'term': 'Hyperlipoproteinemia Type I'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2016-01-12', 'studyFirstSubmitQcDate': '2016-01-13', 'lastUpdatePostDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Lipoprotein lipase levels', 'timeFrame': '10-15 minutes post-heparin adminstration', 'description': 'Blood will be drawn after IV heparin administration and run through assay to determine lipoprotein lipase levels.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lipoprotein Lipase Deficiency']}, 'descriptionModule': {'briefSummary': 'This study plans to learn more about measuring Lipoprotein lipase (LPL) activity in humans. LPL is an enzyme in the breakdown of certain types of fats into smaller parts. Lipoprotein lipase deficiency (LPLD) is a very rare genetic disorder in which lipoprotein enzyme is no longer functional. This can cause conditions known as high triglycerides in the blood and inflammation of the pancreas.\n\nInvestigational medications to treat LPLD are currently being developed. In order to see if these medications are effective, it is necessary to be able to accurately measure LPL activity in humans.\n\nLPL activity has been successfully measured in animal models after giving heparin. Heparin is a blood thinner which is approved by the FDA. It is originally used to prevent blood clots. This study will administer heparin to healthy adults through intravenous infusion (IV). Blood samples will be collected before and after the infusion to test LDL levels.\n\nThe purpose of this study is to develop a cheap, more reliable standard for assessment of LPLD in patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Male and female individuals', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. male and females between ages of 20-39\n\nExclusion Criteria:\n\n1. Past history of LPL deficiency\n2. Hypercholesterolemia (Cholesterol \\>200, LDL \\>160, HDL \\<35) hypertriglyceridemia (TG\\>150), any familial lipid disorder\n3. Diabetes mellitus (type 1 or 2)\n4. Uncontrolled hypertension SBP\\>140, DBP\\>90\n5. History of hemorrhagic stroke\n6. Current pregnancy\n7. History of major surgery, invasive procedure or trauma within the last 30 days, or planned major surgery within 30 days after participating in the study\n8. Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 30 days prior to screening\n9. History of allergy to heparin\n10. History of heparin-induced thrombocytopenia\n11. Current smoking\n12. Active ulcerative or angiodysplastic GI diseases\n13. Thrombocytopenia or platelet disorders (Platelet count \\<100,000/UL)\n14. Major health issues which may affect the safety of study subject, including but not limited to:\n\n * History of chronic kidney disease (eGFR\\<60)\n * Long term use of medications which alter lipid metabolism\n * History of hepatic disease (ALT or AST more than 2 times the upper limit of normal)\n * History of clotting disorders, any type of coagulation factor deficiency, or thrombocytopenia\n * Chronic use of ASA, anticoagulants, platelet inhibitors\n * Use of NSAIDS for more than 2 weeks prior to screening\n * Anemia (hemoglobin \\<13 g/dL)'}, 'identificationModule': {'nctId': 'NCT02656095', 'briefTitle': 'Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment', 'orgStudyIdInfo': {'id': '15-1412'}, 'secondaryIdInfos': [{'id': 'UL1TR001082', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001082', 'type': 'NIH'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Heparin', 'type': 'DRUG', 'description': 'Participants will be given IV heparin in order to release lipoprotein lipase from capillary endothelial cells. Blood will be drawn 10-15 minutes post-heparin administration and run through assay to determine lipoprotein lipase levels.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert Eckel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}