Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-03-03 @ 4:04 PM
Study NCT ID:
NCT02285218
Status:
UNKNOWN
Last Update Posted:
2019-03-18
First Post:
2014-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of New Adipokines and Hepatokines in Prediction of Patients With Metabolic Syndrome or NAFLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma (blood)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2014-11-04', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'new adipokines', 'timeFrame': 'To 8h fasting blood sample', 'description': 'several candidate adipokines and hepatokines to predict diseases will be measured using ELISA'}, {'measure': 'new hepatokines', 'timeFrame': 'To 8h fasting blood sample', 'description': 'several candidate adipokines and hepatokines to predict diseases will be measured using ELISA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Fatty Liver Disease', 'Type 2 Diabetes', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '27045862', 'type': 'DERIVED', 'citation': 'Lee YH, Lee SG, Lee CJ, Kim SH, Song YM, Yoon MR, Jeon BH, Lee JH, Lee BW, Kang ES, Lee HC, Cha BS. Association between betatrophin/ANGPTL8 and non-alcoholic fatty liver disease: animal and human studies. Sci Rep. 2016 Apr 5;6:24013. doi: 10.1038/srep24013.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the predictive roles of adipokines and hepatokines to detect non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.\n\nTo examine the association or effects of clinical and biochemical factors (lab results and medication, etc.) on serum levels of adipokines and hepatokines in certain subjects with non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects are recruited from either patients who visit out-patient clinics (Diabetes center in Severance hospital) or healthy volunteers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. dyslipidemia 1. serum triglyceride≥150mg/dl, or taking medication to lower triglyceride levels (e.g. fibrates, niacin, omega-3, etc.) or 2. serum LDL-C≥100mg/dl, or taking medication to lower LDL-C levels (e.g. statin, ezetimibe, etc.)\n2. type 2 diabetes 1. defined according to the ADA guideline (DM definition) or 2. taking any anti-diabetic medications\n3. non-alcoholic fatty liver disease (NAFLD) 1. diagnosed as having fatty liver by ultrasonogram or 2. diagnosed as having fatty liver by transient elastogram (Fibroscan) or 3. diagnosed as having fatty liver by abdomina CT scan\n4. Normal control 1. should not be included in other groups as above and 2. not taking any medication related to diabetes and dyslipidemia and 3. BMI \\<25kg/m2\n\nExclusion Criteria:\n\n1. subjects who refused to agree with informed consents\n2. subjects with organ-transplantation\n3. serum creatinine ≥1.5mg/dl\n4. pregnant women\n5. liver cancer or pancreatic cancer\n6. subjects with chronic hepatitis B or C virus infection\n7. for NAFLD group, subjects with excessive alcohol consumption (men: ≥210g of alcohol per week, women: ≥140g of alcohol per week)'}, 'identificationModule': {'nctId': 'NCT02285218', 'briefTitle': 'Role of New Adipokines and Hepatokines in Prediction of Patients With Metabolic Syndrome or NAFLD', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2014-0073'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1) Normal control', 'description': 'metabolically healthy with no obesity', 'interventionNames': ['Other: serum blood sampling']}, {'label': '2) dyslipidemia', 'description': 'high triglyceride levels or LDL-C levels', 'interventionNames': ['Other: serum blood sampling']}, {'label': '3) type 2 diabetes', 'description': "defined in 'inclusion criteria'", 'interventionNames': ['Other: serum blood sampling']}, {'label': '4) non-alcoholic fatty liver disease', 'description': "defined in 'inclusion criteria'", 'interventionNames': ['Other: serum blood sampling']}], 'interventions': [{'name': 'serum blood sampling', 'type': 'OTHER', 'armGroupLabels': ['1) Normal control', '2) dyslipidemia', '3) type 2 diabetes', '4) non-alcoholic fatty liver disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bong Soo Cha, MD', 'role': 'CONTACT', 'email': 'bscha@yuhs.ac', 'phone': '+82-2-2228-1932'}], 'facility': 'Severance hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Bong Soo Cha, MD', 'role': 'CONTACT', 'email': 'bscha@yuhs.ac', 'phone': '+82-2-2228-1932'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}