Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06059833
Status:
UNKNOWN
Last Update Posted:
2023-09-29
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum Magnesium Level in Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-02', 'releaseDate': '2025-06-17'}], 'estimatedResultsFirstSubmitDate': '2025-06-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-09-22', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'magnesium perecentage', 'timeFrame': '1 year', 'description': 'evaluate serum Mg level in type 2 DM patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '33466568', 'type': 'BACKGROUND', 'citation': 'Zheng L, Zhu X, Yang K, Zhu M, Farooqi AA, Kang D, Sun M, Xu Y, Lin X, Feng Y, Liang F, Zhang F, Linhardt RJ. Correction: Zheng, L., et al. PBN11-8, a Cytotoxic Polypeptide Purified from Marine Bacillus, Suppresses Invasion and Migration of Human Hepatocellular Carcinoma Cells by Targeting Focal Adhesion Kinase Pathways. Polymers 2018, 10, 1043. Polymers (Basel). 2021 Jan 5;13(1):166. doi: 10.3390/polym13010166.'}, {'pmid': '32872570', 'type': 'BACKGROUND', 'citation': 'Galicia-Garcia U, Benito-Vicente A, Jebari S, Larrea-Sebal A, Siddiqi H, Uribe KB, Ostolaza H, Martin C. Pathophysiology of Type 2 Diabetes Mellitus. Int J Mol Sci. 2020 Aug 30;21(17):6275. doi: 10.3390/ijms21176275.'}, {'pmid': '33499378', 'type': 'BACKGROUND', 'citation': 'Piuri G, Zocchi M, Della Porta M, Ficara V, Manoni M, Zuccotti GV, Pinotti L, Maier JA, Cazzola R. Magnesium in Obesity, Metabolic Syndrome, and Type 2 Diabetes. Nutrients. 2021 Jan 22;13(2):320. doi: 10.3390/nu13020320.'}, {'pmid': '31713111', 'type': 'BACKGROUND', 'citation': 'Feng J, Wang H, Jing Z, Wang Y, Cheng Y, Wang W, Sun W. Role of Magnesium in Type 2 Diabetes Mellitus. Biol Trace Elem Res. 2020 Jul;196(1):74-85. doi: 10.1007/s12011-019-01922-0. Epub 2019 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'Diabetes mellitus (DM) is a chronic metabolic disorder characterized by persistent hyperglycemia. It may be due to impaired insulin secretion, resistance to peripheral actions of insulin, or both . Chronic hyperglycemia in synergy with the other metabolic aberrations in patients with diabetes mellitus can cause damage to various organ systems, leading to the development of disabling and life-threatening health complications, most prominent of which are microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular complications leading to a 2-fold to 4-fold increased risk of cardiovascular diseases Mg2+ deficiency is usually identified by the measurement of serum Mg2+ concentration. Hypomagnesemia is defined by a serum Mg2+ concentration \\< 0.75 mmol/L, but a deficiency due to low dietary intake in otherwise healthy people is uncommon. Although overt signs of clinical Mg2+ deficiency are not routinely recognized in the healthy population, relatively low Mg2+ intake and/or Mg2+ status have been shown to be associated with chronic diseases, including cardiovascular disease, T2DM, osteoporosis, pulmonary disease, depression, migraine headaches, inflammation, and cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Type 2 Diabetes Mellitus according to WHO criteria.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Type 2 Diabetes Mellitus according to WHO criteria.\n\nExclusion Criteria:\n\n* • Renal failure patients.\n\n * Type I DM patients.\n * Acute pancreatitis.\n * Hyperthyroidism.\n * Hyperparathyroidism.\n * Malignancies.\n * Patients on loop/thiazide diuretics.\n * Patients on Mg supplement.\n * Patients on Mg containing antacids.\n * Any other conditions causing low Mg levels were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06059833', 'briefTitle': 'Serum Magnesium Level in Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Serum Magnesium Level in Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'Soh-Med-23-07-14MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cases group', 'interventionNames': ['Diagnostic Test: Magnesium']}, {'label': 'control group', 'interventionNames': ['Diagnostic Test: Magnesium']}], 'interventions': [{'name': 'Magnesium', 'type': 'DIAGNOSTIC_TEST', 'description': 'The aim of the study is to evaluate serum Mg level in type 2 DM patients.', 'armGroupLabels': ['cases group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'hassnaa M kamel, resident', 'role': 'CONTACT', 'email': 'hasnaamohamed@med.sohage.edu.eg', 'phone': '01009700227'}, {'name': 'Elham o Hamd, professor', 'role': 'CONTACT', 'phone': '01063090309'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident-clinical pathology department-sohag hospital university', 'investigatorFullName': 'Hasnaa Mohamed Kamel', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-17', 'type': 'RELEASE'}, {'date': '2025-07-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hasnaa Mohamed Kamel, Resident-clinical pathology department-sohag hospital university, Sohag University'}}}}