Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 7:10 AM
Study NCT ID:
NCT04437459
Status:
COMPLETED
Last Update Posted:
2020-06-18
First Post:
2020-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reliability of the Change in Triglycerides after a High-Fat Meal', 'timeFrame': 'The two fat tolerance tests are separated by 1 week.', 'description': 'Participants complete two fat tolerance tests. In each test, triglycerides are measured in blood immediately before and 4 hours after consumption of a high-fat meal. The reliability/agreement in measuring the triglyceride change between the 2 tests is being determined.'}, {'measure': 'Reliability of the Change in Glucose after Ingestion of a Glucose Solution', 'timeFrame': 'The two glucose tolerance tests are separated by 1 week.', 'description': 'Participants complete two glucose tolerance tests. In each test, glucose is measured in blood immediately before and 2 hours after consumption of a pure glucose solution. The reliability/agreement in measuring the glucose change between the 2 tests is being determined.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemias', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the reliability of a shortened fat tolerance test ("abbreviated fat tolerance test", or "AFTT") for measuring post-meal lipids in human blood. The reliability of the triglyceride results in this test are compared to the reliability of the glucose results from an oral glucose tolerance test (OGTT), a widely-used and clinically accepted metabolic test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Free of chronic disease\n* Normal (healthy) fasting glucose and triglycerides\n\nExclusion Criteria:\n\n* Presence of pace-maker\n* Pregnant\n* Using tobacco products\n* Using medications or dietary supplements that could modify primary outcomes'}, 'identificationModule': {'nctId': 'NCT04437459', 'briefTitle': 'The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University'}, 'officialTitle': 'The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test', 'orgStudyIdInfo': {'id': 'HS1844'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abbreviated Fat Tolerance Test', 'interventionNames': ['Other: High-fat shake']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Glucose Tolerance Test', 'interventionNames': ['Other: Pure glucose solution']}], 'interventions': [{'name': 'High-fat shake', 'type': 'OTHER', 'description': 'Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.', 'armGroupLabels': ['Abbreviated Fat Tolerance Test']}, {'name': 'Pure glucose solution', 'type': 'OTHER', 'description': 'Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.', 'armGroupLabels': ['Oral Glucose Tolerance Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74078-6104', 'city': 'Stillwater', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma State University', 'geoPoint': {'lat': 36.11561, 'lon': -97.05837}}], 'overallOfficials': [{'name': 'Sam R Emerson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}