Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-30 @ 3:17 PM
Study NCT ID:
NCT06163768
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Insulin Resistance in Non-diabetic Acute Coronary Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C044579', 'term': 'insulin resistance factor (uremia)'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Model HOMA-IR', 'timeFrame': 'January 2026', 'description': 'Use SPSS software to analyze data'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Effects of insulin resistance in non-diabetic acute coronary syndrome patients by the homeostasis model assessment index (HOMA2-IR)', 'detailedDescription': 'Help patients know about insulin resistance. If this condition persists for a long time, it will reduce the ability to produce insulin, thereby leading to increased blood sugar levels, causing type 2 diabetes. Helping doctors have a more general view, in order to come up with a strategy more effective monitoring and treatment, preventing diabetes and cardiovascular events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Control group The researcher collected samples from healthy people over 18 years old who came for a health check and were concluded to have good health at the Health Examination Department of University of Medicine and Pharmacy Hospital, Ho Chi Minh City. Not falling within the exclusion criteria and agreeing to participate in the study were included in the study.\n* Researchers -All patients diagnosed with Acute coronary syndrome who were over 18 years old, met the inclusion criteria and did not have exclusion criteria, and agreed to participate in the study were included in the study.\n\nExclusion Criteria:\n\n* Control group\n\n * Patients \\< 18 years old.\n * History of heart disease or stroke\n * Exclude diabetic subjects\n * Exclude subjects at high risk of insulin resistance\n* Researchers\n\n * Have diabetes or have previously been diagnosed with diabetes.\n * Patients \\< 18 years old.\n * The patient does not participate in follow-up examinations and does not follow up treatment at the medical facility.\n * The patient died before reaching the hospital.\n * Patients with severe medical diseases: cirrhosis, cancer, obstructive pulmonary disease chronic obstructive pulmonary disease, chronic heart failure, severe kidney failure.'}, 'identificationModule': {'nctId': 'NCT06163768', 'briefTitle': 'Effects of Insulin Resistance in Non-diabetic Acute Coronary Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Medicine and Pharmacy at Ho Chi Minh City'}, 'officialTitle': 'Effects of Insulin Resistance in Non-diabetic Acute Coronary Syndrome Patients by the Homeostasis Model Assessment Index (HOMA2-IR)', 'orgStudyIdInfo': {'id': 'Nguyen Ngoc Minh Thu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'insulin', 'description': 'This is a prospective study, without intervention in the clinical treatment plan at the hospital', 'interventionNames': ['Procedure: Insulin resistance']}], 'interventions': [{'name': 'Insulin resistance', 'type': 'PROCEDURE', 'description': 'Steps to conduct testing and treatment according to the approved regimen at Ho Chi Minh City University of Medicine and Pharmacy Hospital. The researcher did not intervene in the treatment process.', 'armGroupLabels': ['insulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000', 'city': 'Ho Chi Minh City', 'state': 'Five', 'status': 'RECRUITING', 'country': 'Vietnam', 'facility': 'Medical and Pharmaceutical University Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'centralContacts': [{'name': 'Nguyen Ngoc Minh Thu', 'role': 'CONTACT', 'email': 'nnmthu.ncs.khys.hoasinh23@ump.edu.vn', 'phone': '+84907484296'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Pharmacy at Ho Chi Minh City', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University of Medicine and Pharmacy at Ho Chi Minh City', 'investigatorFullName': 'Nguyen Ngoc Minh Thu', 'investigatorAffiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City'}}}}