Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT03109561
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2017-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apolipoprotein E (ApoE) and Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001057', 'term': 'Apolipoproteins E'}, {'id': 'D008660', 'term': 'Metabolism'}], 'ancestors': [{'id': 'D001053', 'term': 'Apolipoproteins'}, {'id': 'D008074', 'term': 'Lipoproteins'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001059', 'term': 'Apoproteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '2 tablespoons of blood for DNA Testing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2017-04-06', 'studyFirstSubmitQcDate': '2017-04-06', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Urea Nitrogen Output', 'timeFrame': '4 hours', 'description': 'Improve RQ measure accuracy by determining urinary urea nitrogen output in collected urine samples from these subjects.'}, {'measure': 'Genotype', 'timeFrame': '4 hours', 'description': 'Genotype subjects using DNA isolated from collected blood samples.'}], 'primaryOutcomes': [{'measure': 'Indirect Calorimetry', 'timeFrame': '4 hours', 'description': 'Measure resting state respiratory quotient in cognitively normal participants with various ApoE genotypes'}], 'secondaryOutcomes': [{'measure': 'Respiratory Quotient (RQ)', 'timeFrame': '4 hours', 'description': 'Measure RQ during a cognitive challenge in cognitively normal individuals with various ApoE genotypes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Function', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Impaired metabolism and the gene apolipoprotein E (ApoE) are independent risk factors for cognitive impairment and dementia. In humans, there are three major versions of apoE (E): E2, E3, and E4. Some studies suggest that the different versions of apoE have varying effects on whole body and brain metabolism. The goal of this project is to better understand the relationship between apoE and metabolism. This will help investigators identify new targets for the prevention and treatment of cognitive decline and dementia.', 'detailedDescription': "The investigator hopes determine whether a participant's version of ApoE affects their metabolic rate at rest and during a cognitive challenge. To determine this, the investigator will measure basal (resting) metabolic rates using a technique called indirect calorimetry (IC). This is accomplished by wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.\n\nTo more accurately measure the amount of carbohydrates, fats and proteins that the body is metabolizing, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study).\n\nTo determine what version of ApoE the participant inherited, the investigator will conduct a genetic test on DNA isolated from the participant's blood."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cognitively normal and are in good overall health.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* all races/ethnicities\n* ages 18-65\n* cognitively normal\n* good health\n\nExclusion Criteria:\n\n* pregnant or breastfeeding.\n* have a bleeding disorder,\n* have a history of stroke, seizures, Parkinson's disease, history of head injury with loss of consciousness, or other dementing disorder.\n* have a history of alcoholism or drug abuse\n* have a history of schizophrenia or currently suffer from bipolar disorder or major depression.\n* have vision or hearing loss severe enough to interfere with cognitive testing"}, 'identificationModule': {'nctId': 'NCT03109561', 'briefTitle': 'Apolipoprotein E (ApoE) and Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'APOE, Metabolism and Cognitive Function: An Assessment Via Indirect Calorimetry', 'orgStudyIdInfo': {'id': '17-0202-F1G'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Resting State Indirect Calorimetry', 'type': 'OTHER', 'description': 'The investigator will measure the amount of oxygen participants breathe in and the amount of carbon dioxide they breathe out using a portable unit. Participants will be asked wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.'}, {'name': 'ApoE', 'type': 'GENETIC', 'description': 'The investigator will conduct a genetic test on DNA isolated from from the participants blood. Participants will be asked to provide about 2 tablespoons.'}, {'name': 'Metabolism', 'type': 'DIAGNOSTIC_TEST', 'description': 'To more accurately measure the amount of carbohydrates, fats and proteins that the participants bodies metabolize, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study). The total amount of urine to be collected is approximately 4 teaspoons.'}, {'name': 'Cognitive Challenge', 'type': 'OTHER', 'description': 'Participants will be asked to follow simple instructions that are displayed on computer screen.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Lance Johnson1, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lance Johnson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lance Johnson', 'investigatorAffiliation': 'University of Kentucky'}}}}