Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-02-24 @ 3:14 PM
Study NCT ID:
NCT03921203
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ApoB48 Metabolism in Plasma and Interstitial Fluid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Interstitial fluid and blood (serum, plasma and whole blood)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-24', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ApoB48 levels in blood and interstitial fluid', 'timeFrame': '7 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Postprandial increases in the levels of atherogenic chylomicron remnant lipoprotein particles have long been considered a presumable risk factor for the development of atherosclerosis with time, also in normolipidemic subjects. apoB-48 (Chylomicron) in blood is a specific marker for intestinal derived lipoproteins. Specific aim: To determine if apoB-48 containing lipoproteins may appear in IC in the postprandial state after a standard meal and investigate the effect fasting and feeding have on levels of lipids, apolipoproteins and the cholesterol component of lipoproteins in IF and plasma.\n\nMethodology: Intercellular fluid will be collected using the cup technique. IF will be collected in intervals corresponding to different periods after food intake. The IF from these different occasions will then be analysed and compared using FPLC and Elisa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy controls and type 2 diabetes patients over 18 years old, matched for age and gender.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years.\n* For the T2D study group: Diagnosed with type 2 diabetes.\n\nExclusion Criteria:\n\nFor subjects with type 2 diabetes:\n\n* Systemic inflammatory disease that requires active treatment\n* Thyroid disease that requires active treatment\n* Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated\n* Treatment with oral glucocorticoids\n* Levels of SR, TSH, T4 or Hemoglobin in the blood pronouncedly outside the reference range\n* Pregnancy\n\nFor healthy controls:\n\n* Registered disease in the health declaration that requires continuous systemic treatment. Exception to the above: well controlled hypertension in which case the subject should not have treatment with more than one antihypertensive drug, the drug must not be an alpha-blocker or beta-blocker or thiazide diuretic\n* Skin disease that requires active treatment and causes significant changes in the area of the skin that is to be investigated\n* Blood pressure pronouncedly above 140/90\n* Blood test results pronouncedly outside the reference range\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03921203', 'briefTitle': 'ApoB48 Metabolism in Plasma and Interstitial Fluid', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'ApoB48IC2 Metabolism in Plasma and Interstitial Fluid', 'orgStudyIdInfo': {'id': 'ApoB48IC2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Type 2 diabetes patients'}, {'label': 'Healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Stockholm', 'state': 'Huddinge', 'country': 'Sweden', 'facility': 'Patient research centre, Clinic of endocrinology, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Mats Rudling', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mats Rudling', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}