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 — 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
  • 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.

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 patien
    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.

Primary Outcome Measure

•Magnetic resonance imaging of the brain (MRI) with contrast. [ Time Frame: 2 weeks ]

Central Contacts

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