Study to evaluate release of glucose toxicity associated with SGLT2 inhibitors administered in patients with metabolic syndrome in type 2 diabetes
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000019660
- Lead Sponsor
- Medical Corporation KYOSOKAI AMC Nishi Umeda Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
(1)Patients with type 1 diabetes (2)Patients with a history of severe ketosis, diabetic coma, or diabetic pre-coma within 6 months prior to the start of study (3)Patients with severe infection or serious trauma, or in a pre- or post-operative phase (4)Patients with a history of hypersensitivity to the components of the study drug (5)Patients with severe renal dysfunction (eGFR <30 mL/min/1.73 m2) or end-stage renal failure undergoing dialysis (6)Patients with serious hepatic dysfunction (7)Pregnant or lactating women, or those expecting to become pregnant during the study period (8)Patients judged inadequate to enroll in the study at the discretion of principal investigator or subinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Blood glucose-related: HbA1c, fasting glucose, glucagon 2.Insulin secretion-related: fasting insulin, plasma glucose after glucose tolerance test, fasting blood CPR, CPI 3.Insulin resistance: Matsuda Index 4.Metabolic syndrome-related: Abdominal circumference, neutral fat, HDL cholesterol, blood pressure 5.Oxidative stress-related: high-sensitivity CRP, adiponectin
- Secondary Outcome Measures
Name Time Method