Investigation of the Effect of Dapagliflozin on Body Composition and Diet in Japanese Patients with Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes mellitus
- Registration Number
- JPRN-UMIN000019192
- Lead Sponsor
- Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University
- Brief Summary
As a result of treatment with dapagliflozin to 54 Japanese patients with type 2 diabetes for 2 years, body weight was significantly reduced, in addition to the improvement of blood glucose and blood pressure. This study suggested that most of the weight loss was due to the decreases in body fat mass and fatty liver.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1) Patients with type 1 diabetes mellitus or secondary diabetes. 2) Patients with infection, postoperative/preoperative status, or severe trauma. 3) Patients with a history of myocardial infarction, angina pectoris, stroke, cerebral infarction, or transient ischemic attacks (TIA). 4) Patients with diabetic retinopathy requiring photocoagulation or vitreous surgery or those who have undergone any of these operations within one year. 5) Patients with moderate or worse renal dysfunction (eGFR < 45mL/min/1.73m2). 6) Patients with severe hepatic dysfunction (Child-Pugh Class C) or liver cirrhosis. 7) Patients with moderate or severe cardiac failure (New York Heart Association Class III or IV). 8) Patients taking GLP-1 receptor agonists. 9) Pregnant or breast-feeding women, as well as women of childbearing potential or those who plan to become pregnant. 10) Patients with a history of hypersensitivity to the study drug. 11) Patients with severe ketosis, diabetic coma, or precoma. 12) Patients with pacemaker. 13) Other patients who are deemed to be inappropriate for the study by the attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change of body composition (fat content) measured by a body composition analyzer (InBody770K) over the 104-week treatment period.
- Secondary Outcome Measures
Name Time Method 1) Body composition parameters (muscle mass and fat/non-fat ratio). 2) Investigation of dietary behavior and food intake using a questionnaire (BDHQ and DEBQ). 3) Indexes of glycemic control and pancreatic beta-cell function. 4) Indexes of diabetic nephropathy/renal function. 5) Indexes of lipid metabolism. 6) Effects on the bone (bone density, bone formation, and bone metabolism markers)