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NCT Number: NCT06750458

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

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.

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Key information

Conditions

Glioma Dapagliflozin (Forxiga) Dexamethasone Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. •Magnetic resonance imaging of the brain (MRI) with contrast.

    Time frame: 2 weeks

  2. Optic nerve sheath diameter for assessment of intracranial tension.

    Time frame: 2 weeks

Secondary outcomes

  1. Tumor necrosis factor alpha (TNF-α).

    Time frame: 2 weeks

  2. Interlukin-6 (IL-6).

    Time frame: 2 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Maha Khalifa, master

CONTACT

[email protected]

0201092848424

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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