Comparative Study Between Dapagliflozin Versus Dexamethasone Role in Pre-operative Management of Non- Diabetic Brain Tumor Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- •Magnetic resonance imaging of the brain (MRI) with contrast.
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Age: > 75 years old, and <18 years old.
- •Breast feeding female. • Pregnant female.
- •eGFR< 30 mL/minute/1.73 m
- •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).
研究组 & 干预措施
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.
干预措施: Placebo (Drug)
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.
干预措施: Dapagliflozin placebo (Drug)
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.
干预措施: DexamethasoneGroup III (n=25) (Dexamethasone group) (Drug)
结局指标
主要结局
•Magnetic resonance imaging of the brain (MRI) with contrast.
时间窗: 2 weeks
Optic nerve sheath diameter for assessment of intracranial tension.
时间窗: 2 weeks
次要结局
- Tumor necrosis factor alpha (TNF-α).(2 weeks)
- Interlukin-6 (IL-6).(2 weeks)
研究者
Maha Khalifa
PhD Candidate
Tanta University