Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-04 @ 10:04 AM
Study NCT ID:
NCT01980459
Status:
COMPLETED
Last Update Posted:
2016-11-30
First Post:
2013-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007249', 'term': 'Inflammation'}, {'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-29', 'studyFirstSubmitDate': '2013-10-22', 'studyFirstSubmitQcDate': '2013-11-04', 'lastUpdatePostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The magnesium cellular levels will provide a stronger correlation with antiinflammatory indicators compared to the circulating serum levels of magnesium.', 'timeFrame': 'One year', 'description': '50 hypomagnesemic diabetic patients will receive magnesium tablets (\\~recommended dietary allowance)for 3 months and circulating inflammatory indicators will be measured. The blood and cellular levels of magnesium will be measured (before and after treatment) to assess which parameter correlates best with efficacy in lowering inflammation indicators.'}], 'secondaryOutcomes': [{'measure': 'Magnesium supplementation will lower parameters of inflammation in hypomagnesemic diabetic patients.', 'timeFrame': 'One year', 'description': 'Antiinflammatory indicators (CRP, TNF alpha, isoprostane, Hemoglobin A1c etc) will be measured prior to and after 3 months of magnesium supplementation .'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypomagnesemia, Cellular Mg, Inflammation, Diabetes Mellitus'], 'conditions': ['Non-Insulin Dependent Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'In most diabetic patients where low blood magnesium levels occur the important depletion of cellular levels is usually not measured. This study will measure both blood and oral mucosal cell magnesium levels before and after 3 months of supplementation with magnesium tablets (the recommended dietary amount of 336 milligrams per day). These magnesium levels will be correlated with blood levels of indicators of inflammation (eg C reactive protein) to see whether the cellular levels are more reliable than blood levels of magnesium for appropriate treatment of magnesium deficiency in diabetic patients.', 'detailedDescription': 'The anti-inflammatory effects of oral magnesium (Mg) supplementation of diabetic and metabolic syndrome patients with low serum Mg levels have been studied with increased interest in recent years. However, serum magnesium levels only represent less than one percent of total body magnesium; whereas cellular deficiency of Mg is a more reliable parameter to assess repletion of this essential mineral for correlation with indices of inflammation.\n\nThe proposed research will compare the efficacy of a 3 month period of treatment with oral Mg of diabetic patients selected for elevations of CRP, TNFα and other markers of inflammation on cellular and serum levels of Mg.\n\nWe anticipate that 50 hypomagnesemic diabetic patients will be selected for 3 months of supplementation with 336 mg of Mg lactate tablets. The repletion of serum and oral epithelial cell Mg levels will be correlated with responses of CRP, TNFα, substance P, HgbAIc and oxidative/nitrosative (ROS/RNS) stress parameters before and after treatment. Individuals will be selected from the Dasman Diabetes Institute in Kuwait. With completion of these analyses, a collaborative manuscript with joint authorship will be prepared and submitted for publication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have documented hypomagnesemia (serum levels ≤ 1.8 mg/dL or 0.74mmol/L);\n* Be between 20-70 years of age at the time of randomization\n* Have hyperglycemia due to NIDDM metabolic syndrome or obesity\n* Have at least one abnormal indicator of inflammation (e.g. elevated CRP, TNF-α)\n* Have no active infection\n\nExclusion Criteria:\n\n* Currently have significant gastrointestinal disorders (e.g. chronic diarrhea);\n* Have impaired renal function, defined as eGFR \\< 60 mL/min/1.73m2 or serum creatinine \\> 1.3 mg/dL;\n* Are current being treated for hypertension (e.g. ACE inhibitors and diuretics), heart block (e.g. EKG evidence of left bundle branch block) or heart failure (e.g. treated with aldosterone antagonists);\n* Are currently pregnant;\n* Have chronic inflammatory disorders (e.g. psoriasis);\n* Have used of Mg supplements and Mg-rich mineral water within 6 months;'}, 'identificationModule': {'nctId': 'NCT01980459', 'acronym': 'MagInGlu', 'briefTitle': 'Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis', 'orgStudyIdInfo': {'id': 'IRB#071317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium Lactate', 'description': 'Patients will receive 2 tablets twice a day of Magnesium Lactate for 3 months.', 'interventionNames': ['Dietary Supplement: magnesium lactate']}], 'interventions': [{'name': 'magnesium lactate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['MagTabSR'], 'description': 'Patient will be given 4 tablets a day of study supplement (Magnesium Lactate) for 3 months. Magnesium cellular and serum levels will be compared prior and post intervention.', 'armGroupLabels': ['Magnesium Lactate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'The Dasman Diabetes Institute', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}], 'overallOfficials': [{'name': 'William B Weglicki, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'George Washington University'}, {'name': 'Nadia Zghoul, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dasmin Diabetes Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nadia Zghoul, PhD, Dept of Clinical Research', 'class': 'UNKNOWN'}, {'name': 'Dasman Diabetes Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Biochemistry & Molecular Medicine', 'investigatorFullName': 'William Weglicki', 'investigatorAffiliation': 'George Washington University'}}}}