Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
- Sponsor
- Tanta University
- Study ID
- NCT06750458
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Dapagliflozin (Forxiga)
- Dexamethasone
- Glioma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin placebo — DRUGTwenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive Dapagliflozin 10 mg once daily for 14 days pre-operative
- Placebo — DRUGTwenty-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) — DRUGTwenty-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.
Study Details
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.
Key Dates
- Start date
- Aug 20, 2025
- Status verified
- Apr 2025
- Primary completion
- Oct 20, 2026
- Completion
- Dec 20, 2026
Study Design
- Enrollment
- 75 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: GroupⅠ(n=25) (Control group)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.
- Experimental: GroupII (n=25) (Dapagliflozin group)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.
- Active Comparator: Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patienThis 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.
Primary Outcome Measure
•Magnetic resonance imaging of the brain (MRI) with contrast. [ Time Frame: 2 weeks ]
Central Contacts
- Maha Khalifa, master0201092848424
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