Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
Study NCT ID:
NCT04382157
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2020-05-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Magnesium Replacement and Hyperglycemia After Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2020-05-03', 'studyFirstSubmitQcDate': '2020-05-08', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnesium retension at loading test', 'timeFrame': '24 weeks', 'description': 'Difference in magnesium retension at magnesium loading test between before and after oral treatment. Retension defined as percentage of magnesium retained from intravenous magnesium sulphate.'}], 'secondaryOutcomes': [{'measure': 'Plasma glucose (mmol/L)', 'timeFrame': 'Baseline (Before magnesium loading tests)', 'description': 'Change of fasting plasma glucose (mmol/L) between start and the end of supplementation.'}, {'measure': 'Insulin (mg/kg/min)', 'timeFrame': '2 hours oral glucose tolerance test', 'description': 'Change of insulin (mg/kg/min) in OGTT (after 2 hours) between start and the end of supplementation.'}, {'measure': 'C-peptide (nmol/L)', 'timeFrame': '2 hours oral glucose tolerance test', 'description': 'Change of C-peptide (nmol/L) in OGTT (after 2 hours) between start and the end of supplementation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral glucose tolerance test', 'Magnesium hydroxide', 'hyperglycemia'], 'conditions': ['Hypomagnesemia', 'Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'The insulin receptor is dependent on magnesium and hypomagnesemia is associated with increased insulin resistance and decreased insulin secretion and action. Recent data suggest that hypomagnesemia may play a role in development of type 2 diabetes. Kidney transplantation patients have low plasma magnesium levels, partly due to treatment with calcineurin inhibitors. However, the role of magnesium in the development of post-transplant diabetes mellitus (PTDM) is unclear.\n\nThe present study addresses, whether hypomagnesemia is feasible to reverse by oral administration of magnesium.\n\nThe investigators wish to investigate whether oral magnesium supplementation is sufficient to increase magnesium levels in kidney transplant recipients, and if supplementation improves glycemic parameters as measured by an oral glucose tolerance test (OGTT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney transplant recipients more than one year after transplantation\n* Hypomagnesemia (\\< 0.7 mmol/L)\n* Age ≥ 18 years and able to give written informed consent\n\nExclusion Criteria:\n\n* Current treatment with magnesium containing medication or supplements\n* Current medical treatment for diabetes\n* Conditions impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis)\n* Subjects with primary non-graft function and subjects with need of dialysis therapy \\>2 months or graftectomy at any time point after transplantation'}, 'identificationModule': {'nctId': 'NCT04382157', 'briefTitle': 'Magnesium Replacement and Hyperglycemia After Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Magnesium Replacement and Hyperglycemia After Kidney Transplantation', 'orgStudyIdInfo': {'id': '2019/842'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mablet', 'description': 'Mablet 360 mg. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.', 'interventionNames': ['Drug: Mablet 360 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo. Twice daily for 4 weeks. If tolerated trice daily for following 20 weeks. Treatment for 24 weeks in total.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Mablet 360 mg', 'type': 'DRUG', 'description': 'Slow-released magnesium hydroxide', 'armGroupLabels': ['Mablet']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Rasmus Carlsen, MD', 'role': 'CONTACT', 'email': 'r.k.carlsen@studmed.uio.no', 'phone': '004723073544'}], 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'centralContacts': [{'name': 'Rasmus K Carlsen, MD', 'role': 'CONTACT', 'email': 'r.k.carlsen@studmed.uio.no', 'phone': '004723073544'}, {'name': 'Trond Jenssen, Prof, PhD', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Trond Jenssen', 'investigatorAffiliation': 'Oslo University Hospital'}}}}