The investigation of the effectiveness by dapagliflozin on severity of sleep disorder breathing (SDB) among the Japanese patients with type 2 diabetes mellitus - Dapagliflozin-SDB study

Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine0 个研究点目标入组 30 人开始时间: 2015年10月15日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 30

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

After administration of dapagliflozin, fasting glucose and HbA1c decreased significantly. The improvement of 3% ODI was observed in patients with moderate to severe SDB but not mild SDB.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 80years-old（—）
性别: All

入选标准

未提供

排除标准

•contraindication of dapagloflozin, type 1 diabetes mellitus, cancer, history of severe hypoglycemia, ketoacidosis, skin disease during treatment, repeated genital infection and urinary tract infection Sleep disorder related to the otolaryngology disease, neurological disease, hypothyroidism and acromegaly. Severe hepatic insufficiency defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN. Total bilirubin >2.0 mg/dL . Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IgG, Hepatitis B viral antibody IgM, Hepatitis B surface antigen and Hepatitis C virus antibody. History of unstable or rapidly progressing renal disease. Volume depleted patients. Recent Cardiovascular Events in a patient: Acute Coronary Syndrome (ACS) within 2 months prior to enrolment, Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment, Acute Stroke or TIA within two months prior to enrolment, and Less than two months post coronary artery revascularization Pregnant or breastfeeding patients. Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure. Patients using other SGLT2 inhibitor.

研究者

发起方

Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine

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