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

NCT06750458 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 36265MD324/12/24
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioma; Dapagliflozin (Forxiga); Dexamethasone

Outcome Measures

Primary Outcomes (2)

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

  2 weeks

• Optic nerve sheath diameter for assessment of intracranial tension.

  2 weeks

Secondary Outcomes (2)

• Tumor necrosis factor alpha (TNF-α).

  2 weeks

• Interlukin-6 (IL-6).

  2 weeks

Study Arms (3)

GroupⅠ(n=25) (Control group)

PLACEBO COMPARATOR

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.

Drug: Placebo

GroupII (n=25) (Dapagliflozin group)

EXPERIMENTAL

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.

Drug: Dapagliflozin placebo

Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patien

ACTIVE COMPARATOR

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.

Drug: DexamethasoneGroup III (n=25) (Dexamethasone group)

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

GroupII (n=25) (Dapagliflozin group)

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.

GroupⅠ(n=25) (Control group)

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.

Group III (n=25) (Dexamethasone group)This group will include twenty-five non-diabetic glioma patien

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

Related Publications (4)

• Takashima M, Nakamura K, Kiyohara T, Wakisaka Y, Hidaka M, Takaki H, Yamanaka K, Shibahara T, Wakisaka M, Ago T, Kitazono T. Low-dose sodium-glucose cotransporter 2 inhibitor ameliorates ischemic brain injury in mice through pericyte protection without glucose-lowering effects. Commun Biol. 2022 Jul 2;5(1):653. doi: 10.1038/s42003-022-03605-4.

  PMID: 35780235 RESULT

• Shim B, Stokum JA, Moyer M, Tsymbalyuk N, Tsymbalyuk O, Keledjian K, Ivanova S, Tosun C, Gerzanich V, Simard JM. Canagliflozin, an Inhibitor of the Na+-Coupled D-Glucose Cotransporter, SGLT2, Inhibits Astrocyte Swelling and Brain Swelling in Cerebral Ischemia. Cells. 2023 Sep 6;12(18):2221. doi: 10.3390/cells12182221.

  PMID: 37759444 RESULT

• Saeedi S, Rezayi S, Keshavarz H, R Niakan Kalhori S. MRI-based brain tumor detection using convolutional deep learning methods and chosen machine learning techniques. BMC Med Inform Decis Mak. 2023 Jan 23;23(1):16. doi: 10.1186/s12911-023-02114-6.

  PMID: 36691030 RESULT

• Weller M, Wen PY, Chang SM, Dirven L, Lim M, Monje M, Reifenberger G. Glioma. Nat Rev Dis Primers. 2024 May 9;10(1):33. doi: 10.1038/s41572-024-00516-y.

  PMID: 38724526 RESULT

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Maha Khalifa, master

CONTACT

0201092848424; maha142282@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 27, 2024
• Study Start: August 20, 2025
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share