Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients

Phase 3

Not yet recruiting

• Conditions: Glioma; Dapagliflozin (Forxiga); Dexamethasone
• Interventions: Drug: Placebo; Drug: Dapagliflozin placebo; Drug: DexamethasoneGroup III (n=25) (Dexamethasone group)

• Registration Number: NCT06750458
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-24
• Study First Posted: 2024-12-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-22
• Study Start: 2025-08-20
• Primary Completion: 2026-10-20
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GroupⅠ(n=25) (Control group)	Placebo	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)	Dapagliflozin placebo	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	DexamethasoneGroup III (n=25) (Dexamethasone group)	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 Measures

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

Secondary Outcome Measures

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