Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-03-06 @ 3:02 AM
Study NCT ID:
NCT06750458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-22
First Post:
2024-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-20', 'studyFirstSubmitDate': '2024-12-15', 'studyFirstSubmitQcDate': '2024-12-24', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '•Magnetic resonance imaging of the brain (MRI) with contrast.', 'timeFrame': '2 weeks'}, {'measure': 'Optic nerve sheath diameter for assessment of intracranial tension.', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Tumor necrosis factor alpha (TNF-α).', 'timeFrame': '2 weeks'}, {'measure': 'Interlukin-6 (IL-6).', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma', 'Dapagliflozin (Forxiga)', 'Dexamethasone']}, 'referencesModule': {'references': [{'pmid': '35780235', 'type': 'RESULT', 'citation': 'Takashima M, Nakamura K, Kiyohara T, Wakisaka Y, Hidaka M, Takaki H, Yamanaka K, Shibahara T, Wakisaka M, Ago T, Kitazono T. Low-dose sodium-glucose cotransporter 2 inhibitor ameliorates ischemic brain injury in mice through pericyte protection without glucose-lowering effects. Commun Biol. 2022 Jul 2;5(1):653. doi: 10.1038/s42003-022-03605-4.'}, {'pmid': '37759444', 'type': 'RESULT', 'citation': 'Shim B, Stokum JA, Moyer M, Tsymbalyuk N, Tsymbalyuk O, Keledjian K, Ivanova S, Tosun C, Gerzanich V, Simard JM. Canagliflozin, an Inhibitor of the Na+-Coupled D-Glucose Cotransporter, SGLT2, Inhibits Astrocyte Swelling and Brain Swelling in Cerebral Ischemia. Cells. 2023 Sep 6;12(18):2221. doi: 10.3390/cells12182221.'}, {'pmid': '36691030', 'type': 'RESULT', 'citation': 'Saeedi S, Rezayi S, Keshavarz H, R Niakan Kalhori S. MRI-based brain tumor detection using convolutional deep learning methods and chosen machine learning techniques. BMC Med Inform Decis Mak. 2023 Jan 23;23(1):16. doi: 10.1186/s12911-023-02114-6.'}, {'pmid': '38724526', 'type': 'RESULT', 'citation': 'Weller M, Wen PY, Chang SM, Dirven L, Lim M, Monje M, Reifenberger G. Glioma. Nat Rev Dis Primers. 2024 May 9;10(1):33. doi: 10.1038/s41572-024-00516-y.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare between the role of dapagliflozin versus dexamethasone in pre-operative management of non-diabetic glioma patients on levetiracetam as anti-seizure drug.', 'detailedDescription': '* This is a randomized, parallel, and controlled study, which will be conducted on pre-operative non-diabetic glioma patients on levetiracetam as anti-seizure drug. \\* This study will be conducted pending registration at ClinicalTrials.gov.\n* All patients will give their written informed consents.\n* Data of patients will be confidential.\n* Any unexpected risk will be reported to patients and Ethical Committee on time. \\* Randomization will be carried out based on days on hospital admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males \\& females.\n* Age: between 18 and 75 years old.\n* Pre-operative non-diabetic glioma patients on levetiracetam. • Diagnosis will be confirmed by:\n\n * The initial clinical examination.\n * Magnetic resonance imaging of the brain (MRI) with contrast.\n\nExclusion Criteria:\n\n* Age: \\> 75 years old, and \\<18 years old.\n* Breast feeding female. • Pregnant female.\n* eGFR\\< 30 mL/minute/1.73 m2.\n* Patients with diabetes mellitus.\n* Patients with diabetic ketoacidosis.\n* Patients with urinary tract infection.\n* Dehydrated patients till normalized.\n* Lower limb amputation patients.\n* SGLT2 inhibitors hypersensitivity.\n* Severe hepatic patients (child-plug score class-c).'}, 'identificationModule': {'nctId': 'NCT06750458', 'briefTitle': 'Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study Between Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients', 'orgStudyIdInfo': {'id': '36265MD324/12/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'GroupⅠ(n=25) (Control group)', 'description': 'This group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive placebo tablets once daily for 14 days pre-operative.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'GroupII (n=25) (Dapagliflozin group)', 'description': 'This group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive Dapagliflozin 10 mg once daily for 14 days pre-operative.', 'interventionNames': ['Drug: Dapagliflozin placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patien', 'description': 'This group will include twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors who will receive Dexamethasone 8 mg tablets once daily for 14 days pre-operative.', 'interventionNames': ['Drug: DexamethasoneGroup III (n=25) (Dexamethasone group)']}], 'interventions': [{'name': 'Dapagliflozin placebo', 'type': 'DRUG', 'description': 'Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive Dapagliflozin 10 mg once daily for 14 days pre-operative', 'armGroupLabels': ['GroupII (n=25) (Dapagliflozin group)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive placebo tablets once daily for 14 days pre-operative.', 'armGroupLabels': ['GroupⅠ(n=25) (Control group)']}, {'name': 'DexamethasoneGroup III (n=25) (Dexamethasone group)', 'type': 'DRUG', 'description': 'Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive Dexamethasone 8 mg tablets once daily for 14 days pre-operative.', 'armGroupLabels': ['Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patien']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maha Khalifa, master', 'role': 'CONTACT', 'email': 'maha142282@pharm.tanta.edu.eg', 'phone': '0201092848424'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Candidate', 'investigatorFullName': 'Maha Khalifa', 'investigatorAffiliation': 'Tanta University'}}}}