Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-30 @ 7:08 PM
Study NCT ID:
NCT05695651
Status:
UNKNOWN
Last Update Posted:
2023-01-25
First Post:
2023-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Triglyceride Glucose Index and HOMA IR as Predictors of Vascular Complications of DM Type 2
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-03-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-20', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigate the association between TyG index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes', 'timeFrame': 'baseline', 'description': 'Investigate the association between TyG index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes'}], 'secondaryOutcomes': [{'measure': 'Percentage of diabetic patients who developed vascular complications.', 'timeFrame': 'baseline', 'description': 'Percentage of diabetic patients who developed vascular complications.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '* Explore the association between Triglyceride glucose index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes.\n* Which shows better performance for assessing insulin resistance Triglyceride glucose index or HOMA-IR in clinical practice regardless of diabetes status', 'detailedDescription': "Type 2 diabetes mellitus (T2DM) has become a global public health problem. With the improvement of people's living standards and the change of lifestyle, the prevalence of T2DM is increasing year by year.\n\nInsulin resistance (IR) is a manifestation of metabolic abnormalities, also known to be one of the main pathogenic drivers of type 2 diabetes (T2D). The gold standard method to measure insulin resistance is through euglycemic hyperinsulinemic clamp (HIEC). However, it was rarely conducted in clinical settings due to its complex process and high costs. The triglyceride-glucose index (TyG index) is a critical marker, a reliable and straightforward alternative to IR. It based on fasting glucose and triglycerides, it has been proposed as a simple, reliable surrogate measure and less cost-effective for the diagnosis of IR compared with the euglycaemic-hyperinsulinaemic clamp.\n\nIt has been shown that TyG index was significantly elevated in patients with T2D and could be used to identify individuals at high risk for early prevention. Increased TyG index can be used with HbA1C to predict complications in diabetic patients.\n\nThe homeostasis model assessment for IR (HOMA-IR) is a relatively most widely used tool to assess IR and uses insulin and glucose level derived from the fasting state.\n\nPathophysiological studies suggest that IR promotes a pro-inflammatory state and dyslipidemia, which may largely be responsible for arterial stiffness progress.\n\nStudies have shown that insulin resistance is a high-risk factor in the occurrence and development of atherosclerosis.\n\nDiabetic macrovascular disease mainly refers to coronary heart disease, cerebrovascular disease, and peripheral artery disease caused by or combined with T2DM, which is the main cause of death and disability of T2DM.\n\nHigher levels of the TyG index were closely related to a greater risk of CKD and microalbuminuria.\n\nconcluded that diabetic retinopathy was found increased in patients with insulin resistance.\n\nHowever, the serum glucose and lipid levels of hospitalized patients with T2D were often relatively high. It is unknown whether TyG index remains a strong risk predictor of diabetes complications in this group of patients with high incidence rate of chronic complications. Chronic hyperglycemia and insulin resistance could lead to vascular damage and are regulated by multiple pathophysiological processes, Therefore, monitoring insulin resistance is of great significance for the prevention and treatment of T2D and its complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were diagnosed with diabetes type 2 According to American Diabetes Association', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients were diagnosed with diabetes type 2 According to American Diabetes Association\n\nExclusion Criteria:\n\n1. 18 years or young\n2. Type 1 diabetes or other special types of diabetes\n3. Suffering from acute complications of diabetes, severe chronic complications, or malignant tumors\n4. Patients with a diagnosis of urinary tract infection, renal calculi, or primary renal disease.\n5. Evidence of chronic kidney disease.\n6. Evidence of Diabetic Kidney Disease and/or Diabetic Nephropathy'}, 'identificationModule': {'nctId': 'NCT05695651', 'briefTitle': 'Association of Triglyceride Glucose Index and HOMA IR as Predictors of Vascular Complications of DM Type 2', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Association of Triglyceride Glucose Index and HOMA IR as Predictors of Vascular Complications of Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'sallym'}}, 'armsInterventionsModule': {'interventions': [{'name': 'triglyceride glucose index and HOMA IR', 'type': 'DIAGNOSTIC_TEST', 'description': 'TyG index was calculated as formula: ln\\[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL)/2\\].\n\nan insulin resistance score (HOMA-IR) was computed with the formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sally Mamdoh Nathan Wasilly, master', 'role': 'CONTACT', 'email': 'mamdouhsally5@gmail.com', 'phone': '01221553703'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'sahel sleem - assiut', 'investigatorFullName': 'Sally Mamdouh Nathan', 'investigatorAffiliation': 'Assiut University'}}}}