Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-04 @ 5:11 PM
Study NCT ID:
NCT05237895
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2022-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Endocan Levels and Gestational Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-03', 'studyFirstSubmitDate': '2022-02-03', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of diagnostic value of serum endocan levels in patient with gestational diabetes', 'timeFrame': '3 months', 'description': 'Identifying diagnostic value of serum endocan by comparing serum levels of endocan in groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Diabetes', 'Endocan']}, 'descriptionModule': {'briefSummary': 'In diabetic patients, serum endocan level has been significantly increased in patients and the levels on the long-term complications are correlated. Based on the Iinformation obtained from these studies, it can be said that there is a strong association between diabetes and serum endocan levels.', 'detailedDescription': 'It has been shown that endocan level of plasental tissue in gestational diabtes patients is significantly increased when looking at the same week compared with plasenta tissue samples of helathy pregnancy. From the information obtained from these studies, it can be said that there is a strong association between diabetes mellitus and serum endocan levels. investigators aimed to determine the relationship between serum endocan levels and gestational diabetes in the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being pregnant at 24-26 weeks of gestation\n* having oral glucose toleranse screening test\n* age between 18-45 years\n\nExclusion Criteria:\n\n* having in utero mort fetus\n* having a previous diagnosis of diabetes\n* having a multiple pregnancy\n* having a coronary artery disease\n* having preeclampcia\n* having a pregnancy obtained by assisted reproductive technology\n* using cigarette\n* using alcohol'}, 'identificationModule': {'nctId': 'NCT05237895', 'briefTitle': 'Serum Endocan Levels and Gestational Diabetes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'Evaluation of Serum Endocan Levels in Patients With Gestational Diabetes', 'orgStudyIdInfo': {'id': 'GaziosmanpaşaTREHi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with Gestational Diabetes', 'description': 'pregnant women who are at 24-26 weeks of gestational age with positive oral glucose tolerance screening test.', 'interventionNames': ['Diagnostic Test: Serum Endocan Levels']}, {'type': 'OTHER', 'label': 'Healty Pregnants', 'description': 'pregnant women who are at 24-26 weeks of gestational age with normal oral glucose tolerance screening test.', 'interventionNames': ['Diagnostic Test: Serum Endocan Levels']}], 'interventions': [{'name': 'Serum Endocan Levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detection of Serum Endocan Levels and detection of possible diagnostic association with gestational diabetes', 'armGroupLabels': ['Healty Pregnants', 'Patients with Gestational Diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'Gaziosmanpaşa', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpaşa Treh', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'elif yıldız, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gaziosmanpasa Research and Education Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Elif Yıldız', 'investigatorAffiliation': 'Gaziosmanpasa Research and Education Hospital'}}}}