Clinical trial · Interventional
Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
Comparative Study Between Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
NCT06750458CI-TRIAL-00088779not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dapagliflozin (Forxiga) | — | UNRESOLVED | — |
| Dexamethasone | — | UNRESOLVED | — |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dapagliflozin placebo | Drug | — | UNRESOLVED |
| DexamethasoneGroup III (n=25) (Dexamethasone group) | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Males \& females. * Age: between 18 and 75 years old. * Pre-operative non-diabetic glioma patients on levetiracetam. • Diagnosis will be confirmed by: * The initial clinical examination. * Magnetic resonance imaging of the brain (MRI) with contrast. Exclusion Criteria: * Age: \> 75 years old, and \<18 years old. * Breast feeding female. • Pregnant female. * eGFR\< 30 mL/minute/1.73 m2. * Patients with diabetes mellitus. * Patients with diabetic ketoacidosis. * Patients with urinary tract infection. * Dehydrated patients till normalized. * Lower limb amputation patients. * SGLT2 inhibitors hypersensitivity. * Severe hepatic patients (child-plug score class-c).
References
Publications (4)
- RESULTTakashima 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 35780235
- RESULTShim 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 37759444
- RESULTSaeedi 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 36691030
- RESULTWeller 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. PMID 38724526