Clinical trial NCT06750458: Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
Official title: Comparative Study Between Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Glioma
Dapagliflozin (Forxiga)
Dexamethasone
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: •Magnetic resonance imaging of the brain (MRI) with contrast.
timeFrame: 2 weeks
measure: Optic nerve sheath diameter for assessment of intracranial tension.
timeFrame: 2 weeks
Secondary outcomes:
measure: Tumor necrosis factor alpha (TNF-α).
timeFrame: 2 weeks
measure: Interlukin-6 (IL-6).
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.