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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06750458

Enrollment

Registered

2024-12-27

Start date

2025-08-20

Completion date

2026-12-20

Last updated

2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma, Dapagliflozin (Forxiga), Dexamethasone

Brief summary

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.

Detailed description

* 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. * All patients will give their written informed consents. * Data of patients will be confidential. * Any unexpected risk will be reported to patients and Ethical Committee on time. \* Randomization will be carried out based on days on hospital admission.

Interventions

DRUGDapagliflozin placebo

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

DRUGPlacebo

Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors will receive placebo tablets once daily for 14 days pre-operative.

DRUGDexamethasoneGroup III (n=25) (Dexamethasone group)

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
•Magnetic resonance imaging of the brain (MRI) with contrast.	2 weeks
Optic nerve sheath diameter for assessment of intracranial tension.	2 weeks

Secondary

Measure	Time frame
Tumor necrosis factor alpha (TNF-α).	2 weeks
Interlukin-6 (IL-6).	2 weeks

Contacts

Primary ContactMaha Khalifa, master

maha142282@pharm.tanta.edu.eg0201092848424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026