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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groupâ… (n=25) (Control group) | Placebo Comparator | 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. |
|
| GroupII (n=25) (Dapagliflozin group) | Experimental | 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. |
|
| Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patien | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin placebo | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| •Magnetic resonance imaging of the brain (MRI) with contrast. | 2 weeks | |
| Optic nerve sheath diameter for assessment of intracranial tension. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor necrosis factor alpha (TNF-α). | 2 weeks | |
| Interlukin-6 (IL-6). | 2 weeks |
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Inclusion Criteria:
Males & females.
Age: between 18 and 75 years old.
Pre-operative non-diabetic glioma patients on levetiracetam. • Diagnosis will be confirmed by:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maha Khalifa, master | Contact | 0201092848424 | maha142282@pharm.tanta.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35780235 | Result | 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. | |
| 37759444 |
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| Placebo | Drug | Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive placebo tablets once daily for 14 days pre-operative. |
|
| DexamethasoneGroup III (n=25) (Dexamethasone group) | Drug | 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. |
|
| 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. |
| 36691030 | Result | 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. |
| 38724526 | Result | 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. |
| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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