The Hepato-protective Effect of Dapagliflozin in Type 2 Diabetes Mellitus Patients (T2DM) With Nonalcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- leptin (ng/ml)
研究概览
简要总结
The aim of this study is to evaluate the effect of dapagliflozin on liver function of patient with NAFLD and T2DM.
详细描述
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Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
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Ethical committee approval will be obtained from Ethics committee of General Organization for Teaching Hospitals and Institutes.
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About 50 patients who are candidate to detect the hepato-protective effect of Dapagliflozin on non- alcoholic fatty disease, will be recruited from Alexandria Teaching Hospital (EL-Mery), General Organization for Teaching Hospitals and Institutes.
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All participants should agree to take part in this clinical study and will provide informed consent.
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Demographic data; age (year), sex (female/male), weight (kg), height (cm), BMI (kg/m2) will be collected.
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Venous blood samples (5 ml will be collected by a sterile syringe then placed in a suitable sterile tube to be centrifuged, the serum will be reserved and stored at -80°C until the analysis) before, and after receiving medication (Dapagliflozin).
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Measuring outcome:
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The biochemical tests will be done on the patients are alanine aminotransferase (ALT), aspartate aminotransferase (AST), homeostasis model assessment of insulin resistance (HOMA-IR), Hemoglobin A1C (HbA1C), Low-density lipoproteins (LDL), High-density lipoproteins (HDL), Triglycerides (TG), liver fibrosis score, and complete blood count (CBC).
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The molecular tests will be done on the patient are soluble vascular cell adhesion molecule-1 (Svcam-1), adipocytes (e.g. adiponectin, leptin).
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The ultrasound screening will be done at first examination.
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Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
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Results, conclusion, discussion and recommendations will be given.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus patients.
- •HbA1C < 8.
- •Patients were They were having fatty liver changes on abdominal ultrasound and mild to moderate elevation of serum liver enzymes.
- •BMI more than 30
排除标准
- •Patients with a history of alcohol, smoking, uncontrolled diabetes.
- •(HbA1c > 9.0).
- •Hemochromatosis.
- •Thyroid disorders.
- •Renal dysfunction.
- •Cardiac problem.
- •Chronic liver and decompensated liver disease in the form of hepatitis B and C.
研究组 & 干预措施
group (A) for controlled (placebo).
25 patients will recieve placebo for 6 months.
干预措施: Placebo (Other)
group (D) for Dapagliflozin.
25 patients will recieve 10 mg Dapagliflozin daily for 6 months.
干预措施: Dapagliflozin 10mg Tab (Drug)
结局指标
主要结局
leptin (ng/ml)
时间窗: 6 months
leptin by enzyme-linked immunosorbent assay (ELISA).
adiponectin (pg/ml)
时间窗: 6 months
adiponectin by enzyme-linked immunosorbent assay (ELISA).
VCAM-1 (ng/ml)
时间窗: 6 months
VCAM-1 was analyzed in serum using the human VCAM-1 ELISA kits.
次要结局
未报告次要终点
研究者
Rehab Werida
Associate Professor
Damanhour University