Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:23 AM
Study NCT ID:
NCT07467161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Insulin Resistance and Vitamin D in Type 2 Diabetes Mellitus (DM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 165}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of vitamin D level on insulin resistance', 'timeFrame': 'baseline', 'description': 'Evaluation of the association between vitamin D levels and triglyceride-glucose index as a marker of insulin resistance in patients with type 2 DM'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '34965646', 'type': 'BACKGROUND', 'citation': 'Lee SH, Park SY, Choi CS. Insulin Resistance: From Mechanisms to Therapeutic Strategies. Diabetes Metab J. 2022 Jan;46(1):15-37. doi: 10.4093/dmj.2021.0280. Epub 2021 Dec 30.'}, {'pmid': '33766485', 'type': 'BACKGROUND', 'citation': 'Hill MA, Yang Y, Zhang L, Sun Z, Jia G, Parrish AR, Sowers JR. Insulin resistance, cardiovascular stiffening and cardiovascular disease. Metabolism. 2021 Jun;119:154766. doi: 10.1016/j.metabol.2021.154766. Epub 2021 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the study is to evaluate the association between vitamin D levels and triglyceride-glucose index as a marker of insulin resistance in patients with type 2 DM.', 'detailedDescription': 'All eligible patients will be asked to participate in the study after counseling and written consent. The following data will be collected.\n\nI) Demographic \\& baseline data of the participants:\n\n* Gender, age, residence (rural or urban), weight and height.\n* Smoking or alcohol consumption.\n\nII) Medical History of the participants:\n\n* Regarding Type 2 DM: onset of diagnosis, current medications, dosage of medications, adherence to treatment, complications of DM.\n* Other medical disorders: hypertension, thyroid disease.\n\nIII) Clinical and laboratory assessment of the participants:\n\n* Vital signs: Pulse, blood pressure (systolic \\& diastolic), temperature and respiratory rate.\n* Body mass index (BMI): calculated as weight in kilograms divided by the square of height in meters (kg/ m²).\n* Waist circumference of the participants.\n* All participants will be fasting overnight (12 hours), and the blood samples will be drawn in the next morning. All blood biomarkers will be tested in the same laboratory. We will measure the following: Fasting blood glucose (FBG), glycosylated hemoglobin (HbA1c), 25-hydroxyvitamin D, albumin, total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), urea nitrogen (BUN), creatinine (S.cr) and uric acid (UA).\n* The serum concentration of 25(OH)D will be measured using electro-chemi-luminescence immunoassay.\n* Triglyceride-glucose index (TyG) will be calculated as (fasting triglyceride (mg/dL) x fasting glucose (mg/dL)/2).\n* Vitamin D deficiency (VDD) is defined as plasma 25(OH)D \\< 20 ng/mL; values 20-30 ng/mL are considered insufficiency; and values \\> 30 ng/mL are considered sufficiency.\n* For those with vitamin D deficiency (25(OH)D \\< 20 ng/mL); vitamin D supplementation will be added for correction.\n* Follow up of the participants after 3 months: vitamin D level (25-hydroxyvitamin D), Triglyceride-glucose index (TyG), waist circumference and glycemic control reflected by glycosylated hemoglobin (HbA1c).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with type 2 DM', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 2 DM diagnosed based on American Diabetes Association criteria.\n\nExclusion Criteria:\n\n* Patients with type 1 DM or other types of diabetes.\n* Patients with complications of acute DM.\n* Pregnant females.\n* Malignancy.\n* BMI \\> 35 kg/m²\n* Major co-morbidities as end-stage renal disease or liver cell failure.\n* Patients on lipid lowering therapy.\n* Patients on vitamin D supplementation.'}, 'identificationModule': {'nctId': 'NCT07467161', 'acronym': 'DM', 'briefTitle': 'Relationship Between Insulin Resistance and Vitamin D in Type 2 Diabetes Mellitus (DM)', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Vitamin D Deficiency on Insulin Resistance Assessed by Triglyceride Glucose Index in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': 'Type 2 Diabetes mellitus (DM)'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sara Magdy Ahmed Mohammed, MD', 'role': 'CONTACT', 'email': 'dr.sara54.sm@gmail.com', 'phone': '+201098777997'}, {'name': 'Hanaa Mohamed Riad, MD', 'role': 'CONTACT', 'email': 'hanaaried@aun.edu.eg', 'phone': '+201094608083'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Sara Magdy Ahmed Mohammed', 'investigatorAffiliation': 'Assiut University'}}}}