Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-28 @ 8:09 PM
Study NCT ID:
NCT04371133
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2020-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-inflammatory Markers in Endometrioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum blood samples for each participant'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-30', 'studyFirstSubmitDate': '2020-04-25', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Adropin level', 'timeFrame': 'preoperative in the morning or Day 1 in outpatient clinic,preprandial for healthy volunteers', 'description': 'Serum Adropin level in ng/L'}, {'measure': 'Salusin-α', 'timeFrame': 'preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers', 'description': 'Serum Salusin-α level in pg/mL'}, {'measure': 'Netrin-1', 'timeFrame': 'preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers', 'description': 'Serum Netrin-1 level in pg/mL'}, {'measure': 'Nesfatin-1', 'timeFrame': 'preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers', 'description': 'Serum Nesfatin-1 level in ng/L'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometrioma', 'adropin', 'salusin-α', 'netrin-1', 'nesfatin-1', 'insulin resistance'], 'conditions': ['Endometrioma', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'Investigators aimed to measure the serum levels of adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been demonstrated previously, in endometriosis patients and to find out any association of them with insulin resistance.', 'detailedDescription': "Endometriosis is defined as the presence of endometrial gland and stroma outside the endometrial cavity affecting almost 10% of the women of reproductive age. Although benign, it disrupts the quality of life of the inflicted patients through symptoms such as dysmenorrhae, dyspareunia, chronic pelvic pain, and infertility. The pathogenesis of endometriosis has not yet been clearly elucidated, however, recent papers implies an underpinning role of inflammation There is a limited number of studies about the levels of these parameters in endometriosis and to date, no report is available on the levels of adropin and netrin-1 in endometriosis. Likewise, according to the investigator's literature search, no research explaining the association of endometriosis with insulin resistance has yet been published. In present study, in an attempt to describe inflammatory pathways playing a role in endometriosis pathogenesis, Investigators aimed to measure the levels of serum adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been priorly demonstrated, and to find out any association of them with insulin resistance."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Laporoscopically and histopathologically diagnosed 23 endometrioma patients and 25 healthy individuals with no endometrioma constituting the control group were included to this study.', 'genderDescription': 'patients with endometrioma', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n·Histopathologically confirmed diagnosis of endometrioma\n\nExclusion Criteria:\n\n* Any patients with DM,\n* chronic kidney disease (CKD),\n* CAD,\n* heart failure (HF),\n* cerebrovascular accident (CVA),\n* malignancy,\n* rheumatoid disorder,\n* liver disease, and\n* active infections were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04371133', 'briefTitle': 'Anti-inflammatory Markers in Endometrioma', 'organization': {'class': 'OTHER', 'fullName': 'Muğla Sıtkı Koçman University'}, 'officialTitle': 'The Role of Serum Adropin, Salusin-α, Netrin-1, and Nesfatin-1 in Endometrioma and Their Association With Insulin Resistance', 'orgStudyIdInfo': {'id': '22/08/2019-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endometrioma', 'description': 'Endometrioma (n=23)', 'interventionNames': ['Diagnostic Test: Adropin (ng/L)']}, {'label': 'Healthy controls', 'description': 'Healthy controls Healthy volunteers n=25', 'interventionNames': ['Diagnostic Test: Adropin (ng/L)']}], 'interventions': [{'name': 'Adropin (ng/L)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Salusin-α (pg/mL)', 'Netrin-1 (pg/mL)', 'Nesfatin-1 (ng/mL)'], 'description': 'Thawed samples were measured on a Molecular Devices SpectraMax i3 Multi-Mode, Microplate Reader (batch number: SER 35 370-1448, made in Austria) using enzyme linked immunosorbent assay (ELISA).', 'armGroupLabels': ['Endometrioma', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48000', 'city': 'Muğla', 'country': 'Turkey (Türkiye)', 'facility': 'Mugla Sıtkı Kocman University Faculty of Medicine', 'geoPoint': {'lat': 37.21807, 'lon': 28.3665}}], 'overallOfficials': [{'name': 'Burak Sezgin, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mugla Sıtkı Kocman University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muğla Sıtkı Koçman University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Burak Sezgin', 'investigatorAffiliation': 'Muğla Sıtkı Koçman University'}}}}