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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Glioma; Dexamethasone; Dapagliflozin (Forxiga)
• Intervention / Treatment: Drug: Placebo; Drug: Dapagliflozin placebo; Drug: DexamethasoneGroup III (n=25) (Dexamethasone group)

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 Type: Interventional
• Enrollment (Estimated): 75
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Maha Khalifa, master; Phone Number: 0201092848424; Email: maha142282@pharm.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Placebo; Twenty-five non-diabetic glioma patients on levetiracetam, and not on SGLT2 inhibitors 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.	Drug: Dapagliflozin 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
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.	Drug: DexamethasoneGroup 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2025
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Sodium-Glucose Transporter 2 Inhibitors; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Dapagliflozin
• Other Study ID Numbers: 36265MD324/12/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes