Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-20 @ 1:32 PM
Study NCT ID:
NCT01472120
Status:
UNKNOWN
Last Update Posted:
2011-11-16
First Post:
2011-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adiponectin and Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease (NAFLD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-15', 'studyFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For laboratory analyses, the collection of all blood samples from the study participants.', 'timeFrame': 'Collection of blood samples in one year and analyses of data in 3 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': 'In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus.', 'detailedDescription': 'In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes.\n\nM2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus. In addition, these forms also are related to insulin resistance and inflammation in adipose tissue.\n\nToday, there is no study that investigate the role of adiponectin an anti-inflammatory adipokine, on macrophage polarization in non-alcoholic fatty liver disease.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A sample of male outpatients with histologically proven NAFLD, who attended the outpatient clinic of the Gastroenterology Department, Gulhane School of Medicine, Ankara, Turkey', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Persistently (at least 6 months) elevated aminotransferases\n* Ultrasonographic presence of bright liver without any other liver or biliary tract disease\n* Liver histology compatible with a diagnosis of NASH or SS\n\nExclusion Criteria:\n\n* A history of alcohol consumption \\>40 g/wk, as assessed by a detailed interview extended to family members\n* Morbid obesity \\[body mass index (BMI) ≥40 kg/m2\\], hypertension\n* Positive blood markers of viral, autoimmune, or celiac disease\n* Abnormal copper metabolism or thyroid function tests\n* A diagnosis of T2DM and systemic arterial hypertension\n* Total cholesterol (TC) ≥250 mg/dL, triglycerides (TG) ≥400 mg/dL, exposure to occupational hepatotoxins or drugs known to affect glucose and lipid metabolism'}, 'identificationModule': {'nctId': 'NCT01472120', 'briefTitle': 'Adiponectin and Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease (NAFLD)', 'organization': {'class': 'OTHER', 'fullName': 'Gulhane School of Medicine'}, 'officialTitle': 'The Relationship of Adiponectin With Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease', 'orgStudyIdInfo': {'id': 'NASH-macrophage'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'P and C', 'description': 'P: NAFLD patients\n\nC: Healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06018', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gastroenterology Department, Gulhane School of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'halil genc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gulhane Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulhane School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gulhane School of Medicine', 'investigatorFullName': 'Halil Genc', 'investigatorAffiliation': 'Gulhane School of Medicine'}}}}