Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 12:50 PM
Study NCT ID:
NCT05663632
Status:
UNKNOWN
Last Update Posted:
2022-12-23
First Post:
2022-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triglyceride-Glucose Index In Heart Failure Patients In Sohag University Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-26', 'releaseDate': '2024-02-07'}], 'estimatedResultsFirstSubmitDate': '2024-02-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2022-12-15', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Triglyceride-Glucose Index in Heart Failure Patients', 'timeFrame': '6 months', 'description': 'identify the relationship between Triglyceride-Glucose Index and heart failure patients in Sohag University hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'triglyceride-glucose index'], 'conditions': ['Heart Failure', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '33069326', 'type': 'BACKGROUND', 'citation': 'GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.'}, {'pmid': '25557121', 'type': 'BACKGROUND', 'citation': 'Davison B, Cotter G. Why is heart failure so important in the 21st century? Eur J Heart Fail. 2015 Feb;17(2):122-4. doi: 10.1002/ejhf.219. Epub 2014 Dec 30. No abstract available.'}, {'pmid': '9581716', 'type': 'BACKGROUND', 'citation': 'Miller M, Seidler A, Moalemi A, Pearson TA. Normal triglyceride levels and coronary artery disease events: the Baltimore Coronary Observational Long-Term Study. J Am Coll Cardiol. 1998 May;31(6):1252-7. doi: 10.1016/s0735-1097(98)00083-7.'}, {'pmid': '22795290', 'type': 'BACKGROUND', 'citation': 'Shaye K, Amir T, Shlomo S, Yechezkel S. Fasting glucose levels within the high normal range predict cardiovascular outcome. Am Heart J. 2012 Jul;164(1):111-6. doi: 10.1016/j.ahj.2012.03.023.'}]}, 'descriptionModule': {'briefSummary': 'study the relationship between Triglyceride glucose index and heart failure patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be divided into2 groups, as following:\n\nGroup (1) Heart Failure patients (100 patients) Group (2) control group(100 person)\n\nAll groups will be subjected to :\n\n1. Complete history taking with special emphasis on Age ,Sex, Smoking, Diabetes mellitus and Hypertension.\n2. A thorough clinical examination will stress on:\n\n1- Heart rate (b.p.m.). 2-Systolic BP (mmHg). 3-BMI calculated as the ( weight (kg)/height (m)2). 3-The following investigations will be done to every subject:\n\n1. FBG (mg/dL)\n2. FTG, (mg/dL)\n3. Total cholesterol (TC) (mg/dL)\n4. SCr (mg/dL)\n5. Echocardiography\n\nTyG index is calculated as ln \\[fasting triglyceride (mg/dL) \\* fasting glucose (mg/dL) / 2\\]', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Heart Failure patients attend to sohag university hospital aged above 18 year old .\n\nExclusion Criteria:\n\n* Patients on lipid lowering medications\n* Patients on antidiabetic drugs\n* Patients with comorbidities eg liver cirrhosis or malignancy'}, 'identificationModule': {'nctId': 'NCT05663632', 'briefTitle': 'Triglyceride-Glucose Index In Heart Failure Patients In Sohag University Hospital', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Triglyceride-Glucose Index In Heart Failure Patients In Sohag University Hospital', 'orgStudyIdInfo': {'id': 'Soh-Med-22-12-04'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1 heart failure patients'}, {'label': 'Group 2 controle'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Aliaa k Khyry, resident doctor', 'role': 'CONTACT', 'email': 'aliaakhairy@med.sohag.edu.eg', 'phone': '01067655291'}, {'name': 'Ali T Taha, professor', 'role': 'CONTACT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident at internal medicine department', 'investigatorFullName': 'Aliaa Khairy Shabaan', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-02-07', 'type': 'RELEASE'}, {'date': '2024-07-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Aliaa Khairy Shabaan, resident at internal medicine department, Sohag University'}}}}