Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-31 @ 4:22 AM
Study NCT ID:
NCT05602532
Status:
UNKNOWN
Last Update Posted:
2022-11-02
First Post:
2022-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triglyceride-Glucose Index in Diabetic Nephropathy in Type 2diaberes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2022-10-28', 'studyFirstSubmitQcDate': '2022-10-28', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TyG index in type 2diaberes Mellitus', 'timeFrame': 'Baseline', 'description': 'Detecting the association between the TyG index and diabetic nephropathy in type 2 diabetes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '29219149', 'type': 'BACKGROUND', 'citation': 'Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018 Feb;14(2):88-98. doi: 10.1038/nrendo.2017.151. Epub 2017 Dec 8.'}, {'pmid': '12020339', 'type': 'BACKGROUND', 'citation': 'Beckman JA, Creager MA, Libby P. Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA. 2002 May 15;287(19):2570-81. doi: 10.1001/jama.287.19.2570.'}, {'pmid': '16022668', 'type': 'BACKGROUND', 'citation': 'Yamagishi S, Imaizumi T. Diabetic vascular complications: pathophysiology, biochemical basis and potential therapeutic strategy. Curr Pharm Des. 2005;11(18):2279-99. doi: 10.2174/1381612054367300.'}, {'pmid': '29155497', 'type': 'BACKGROUND', 'citation': 'Liang S, Cai GY, Chen XM. Clinical and pathological factors associated with progression of diabetic nephropathy. Nephrology (Carlton). 2017 Dec;22 Suppl 4:14-19. doi: 10.1111/nep.13182.'}, {'pmid': '30048164', 'type': 'BACKGROUND', 'citation': 'Lee MY, Hsiao PJ, Huang JC, Hsu WH, Chen SC, Chang JM, Shin SJ. ASSOCIATIONS BETWEEN TRIGLYCERIDE/HIGH-DENSITY LIPOPROTEIN CHOLESTEROL RATIO AND MICRO- AND MACROANGIOPATHIES IN TYPE 2 DIABETES MELLITUS. Endocr Pract. 2018 Jul;24(7):615-621. doi: 10.4158/EP-2017-0254.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to investigate the associations between the TyG index and diabetic nephropathy in patients with type2 DM .', 'detailedDescription': 'the triglyceride-glucose (TyG) index was proposed as a simple and reliable surrogate marker of IR, and it has been reported to be closely correlated with the HOMA-IR index. The TyG index has the advantage of being applicable in clinical practice since both triglyceride and glucose levels are routinely measured and the cost of these measurements is low.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'There will be no risk for the patients during the study Confidentiality will be assured. The participants will be informed about the research and they will hsve the right to refuse to participate.\n\nWritten consents will be obtained from all the participants; illiterate participants will give their consent by fingerprints.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with type 2 DM\n\nExclusion Criteria:\n\n\\- (1) Individuals with obstructive uropathy, severe heart failure, stroke, liver disease, cancer, autoimmune disease (2) Pregnant woman. (3)End stage renal disease patients on dialysis ( glomerular filtration rate \\<15 mL/min/1.73 m2) or renal transplantation.\n\n(4) Type 1 Diabetic patient. (5) Albuminuria due to non-diabetic renal disease'}, 'identificationModule': {'nctId': 'NCT05602532', 'briefTitle': 'Triglyceride-Glucose Index in Diabetic Nephropathy in Type 2diaberes Mellitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Triglyceride-Glucose Index in Diabetic Nephropathy in Type 2diaberes Mellitus Patients', 'orgStudyIdInfo': {'id': 'TYG index in DN in type 2 DM'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aya Abo Eyosr Garhey', 'role': 'CONTACT', 'email': 'Ayayosry285@gmail.com', 'phone': '01092606888'}, {'name': 'Salah Abdelazeem Argoon', 'role': 'CONTACT', 'email': 'Argoons@yahoo.com', 'phone': '01019683366'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Aya Abo Elyosr Garhey Yonis', 'investigatorAffiliation': 'Assiut University'}}}}