useogliflozin Ehime Diabetes Study (LED study)
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-UMIN000023649
- Lead Sponsor
- Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
contraindication of Luseogliflozin, 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change of HbA1c, fasting glucose level, energy intake, and eating behavior. The association between energy intake and HbA1c.
- Secondary Outcome Measures
Name Time Method Weight, Abdominal circumference, Lipid profile, liver function test, renal function, heart function, and organ damage marker. The severity of nocturia and sleep time. The frequency of hypoglycemia. The change of intestinal bacterial flora.