Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-14 @ 5:32 AM
Study NCT ID:
NCT05647902
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2022-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Asprosin in Periodontitis and Acute Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-19', 'studyFirstSubmitDate': '2022-12-04', 'studyFirstSubmitQcDate': '2022-12-04', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asprosin Levels', 'timeFrame': 'two weeks', 'description': 'Determination of asprosin levels by making biochemical analyzes from serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Periodontal Diseases']}, 'referencesModule': {'references': [{'pmid': '27087445', 'type': 'RESULT', 'citation': 'Romere C, Duerrschmid C, Bournat J, Constable P, Jain M, Xia F, Saha PK, Del Solar M, Zhu B, York B, Sarkar P, Rendon DA, Gaber MW, LeMaire SA, Coselli JS, Milewicz DM, Sutton VR, Butte NF, Moore DD, Chopra AR. Asprosin, a Fasting-Induced Glucogenic Protein Hormone. Cell. 2016 Apr 21;165(3):566-79. doi: 10.1016/j.cell.2016.02.063. Epub 2016 Apr 14.'}, {'pmid': '32153505', 'type': 'RESULT', 'citation': 'Yuan M, Li W, Zhu Y, Yu B, Wu J. Asprosin: A Novel Player in Metabolic Diseases. Front Endocrinol (Lausanne). 2020 Feb 19;11:64. doi: 10.3389/fendo.2020.00064. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'Asprosin, a recently discovered glucogenic adipokine, is mainly synthesized by white adipose tissue and released during fasting. Appetite, glucose metabolism, insulin resistance, cell apoptosis, etc. asprosin is associated with diseases such as diabetes, obesity, polycystic ovary syndrome, and cardiovascular diseases. Periodontal tissue may act as a source of endocrine-like inflammatory mediators (such as TNF-α, IL-6 and IL-1) that are important in periodontal inflammation and can affect glucose and lipid metabolism. Production of TNF-α and IL-6 in adipose tissues strengthens the relationship between cardiovascular diseases and periodontitis. Investigators postulated that asprosin may be a candidate for explaining the triangular relationship between cardiovascular and periodontal disease.', 'detailedDescription': 'Periodontal disease is a chronic, multifactorial, and infectious disease caused by bacteria. It is characterized by the formation of an inflammatory response in the supporting bone and connective tissue against microbial dental plaque, and the nature of the resulting inflammatory response determines the course of periodontal disease. Cardiovascular and periodontal diseases are closely related, presenting a triad association. Asprosin circulates in the blood at nanomolar levels and is taken to the liver, where it activatesinvestigators the G protein-cAMP-PKA pathway, causing rapid glucose release into the circulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study was carried out on 120 patients, 50 admitted to Atatürk University Medical Faculty Heart Center with SD elevation myocardial infarction and 70 who applied to Atatürk University Faculty of Dentistry. Patients who consent to participate in the study on a randomized basis and comply with the inclusion criteria are divided into periodontitis and healthy groups after the periodontal examination. Body mass index was evaluated', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Healthy group\n\n* All individuals were generally healthy,\n* non-smoking For Myocard Infarctus group\n* patients with ST elevation of Myocardial Infactus\n* patient with less than ten teeth\n\nExclusion Criteria:\n\n* Smokers or those with diabetes or other inflammatory disease\n* Pregnant or breastfeeding women\n* None had undergone periodontal therapy and/or antibiotic therapy in the past 6 months.\n* None has a contagious disease such as HIV or AIDS'}, 'identificationModule': {'nctId': 'NCT05647902', 'briefTitle': 'Association of Asprosin in Periodontitis and Acute Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Serum Asprosin Concentrations in Patients With Periodontitis and Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'MIC3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Group', 'description': '70 systemically healthy patients; 35 healthy gingiva is divided into 2 subgroups, 35 of which are periodontitis. Asprosin levels will be examined biochemically in serum samples taken from patients.', 'interventionNames': ['Diagnostic Test: Serum samples will be collected. Asprosin levels will be determined by biochemical analysis']}, {'label': 'Myocard Infactus Group', 'description': '50 patients with myocardial infarction; 25 healthy gingiva is divided into 2 subgroups, 25 of which are periodontitis. Asprosin levels will be examined biochemically in serum samples taken from patients.', 'interventionNames': ['Diagnostic Test: Serum samples will be collected. Asprosin levels will be determined by biochemical analysis']}], 'interventions': [{'name': 'Serum samples will be collected. Asprosin levels will be determined by biochemical analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum samples will be collected from both groups for biochemical analysis.', 'armGroupLabels': ['Healthy Group', 'Myocard Infactus Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk University Faculty of Dentistry', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Oğuzhan Birdal, Asist. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ataturk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sema Nur Sevinc', 'investigatorAffiliation': 'Ataturk University'}}}}