Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-05 @ 6:36 PM
Study NCT ID:
NCT00860392
Status:
COMPLETED
Last Update Posted:
2017-11-27
First Post:
2009-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2009-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-23', 'studyFirstSubmitDate': '2009-03-11', 'studyFirstSubmitQcDate': '2009-03-11', 'lastUpdatePostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in healthy lean subjects', 'timeFrame': '5 hours'}], 'secondaryOutcomes': [{'measure': 'Effects of increase in serum free fatty acid levels on ketogenesis as measured using a isotopic tracer and serum ketone body concentration in obese subjects', 'timeFrame': '5 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study will compare two approaches to the measurement of fatty acid oxidation (ketone body flux and ketone body concentration) and determine which method demonstrates superior sensitivity and variability in the detection of moderate increases in ketogenesis rates.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has a Body Mass Index of 18-25 kg/m2 OR 29-40 kg/m2\n* Subject has been a nonsmoker or has not used nicotine for the past 6 months\n\nExclusion Criteria:\n\n* Subject has a history of diabetes mellitus\n* Subject has a history of stroke, chronic seizures, or other neurological disorder\n* Subject has a history of cancer, except certain skin cancers\n* Subject consumes more than 3 alcoholic beverages per day\n* Subject consumes more than 6 servings of caffeinated beverages per day\n* Subject has multiple and/or severe allergies to food or drugs\n* Subject has allergy or sensitivity to eggs or soy\n* Subject regularly uses illicit drugs or has a history of drug or alcohol abuse'}, 'identificationModule': {'nctId': 'NCT00860392', 'briefTitle': 'A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation', 'orgStudyIdInfo': {'id': '0000-110'}, 'secondaryIdInfos': [{'id': '2009_560'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Biomarker evaluation', 'interventionNames': ['Drug: Stable isotope tracer (13-C(4)-BHB)']}], 'interventions': [{'name': 'Stable isotope tracer (13-C(4)-BHB)', 'type': 'DRUG', 'description': 'A stable isotope tracer (13-C(4)-BHB), a commercially available lipid emulsion, and heparin will be administered intravenously. Ketone body concentrations will be measured before beginning the infusion, at approx. 135 minutes, and at approx. 255 minutes.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}