JPRN-UMIN000026791招募中未知
A prospective Randomized study comparing the effects of Empagliflozin versus Sitagliptin on Intra hepatic lipid content and hepatic insulin resistance in type 2 diabetes patients / Resistance study
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Toho University Omori Medical Center0 个研究点目标入组 44 人开始时间: 2017年3月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are included in this study.
- •1. Type 2 diabetic patients with HbA1c below 10% at the time of consenting
- •2. Female and male patients are 20 years old or older and younger than 75 years old
- •3. Patients who can take liver biopsy for the purpose of evaluation or diagnosis of non-alcohol fatty liver disease
- •4. Patients with BMI 22 kg/m2 or higher
- •5. Patients who can provide their written consent for participation of this study
排除标准
- •Patients who fall into any of the following criteria are excluded from participating in the study.
- •1. Patients with type 1 diabetes or secondary diabetes
- •2. Patients with BMI lower than 22 kg/m2
- •3. Patients with moderate to severe renal function disease or at the final stage of renal failure (eGFR lower than 45 mL/min/1.73 m2)
- •4. Patients who had stroke or cerebral infarction within 12 weeks before giving their consent
- •5. Patients with any medical history of myocardial infarction, angina pectoris, or currently with atrial fibrillation
- •6. Patients with any infectious disease
- •7. Patients with malignancy (However, those who have completed treatment and/or show no redevelopment of malignancy, as well as manifest some degree of remission can be considered to be participants of this study)
- •8. Patients with connective tissue disease (However, those T2DM patients who have treated with prednisolone 5 mg or less and show stable conditions can be considered to be participants of this study)
- •9. Patients with hepatocirrhosis
- •10. Patients with viral or autoimmune, or drug-induced hepatic disorder
- •11. Patients who are alcoholic or excessive drinkers
- •12. Patients who are currently pregnant, possibly pregnant, or breast-feeding during the study
- •13. Patients have a medical history of hypersensitivity to the study drugs
- •14. Patients who are in the category that the study drugs are prohibited to use
- •15. Patients with Hb below 12 g/dl
- •16. Patients with other conditions that investigators/physicians think inappropriate to be in the study
研究者
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