Type 2 Diabetes mellitus
Conditions
Interventions
The study period has a duration of 104 weeks from the time of enrollment. The investigator will initiate treatment with dapagliflozin and will aim to achieve the target levels in the Treatment Guide f
7.0%, fasting blood glucose <
130 mg/dL, and 2-hour postprandial blood glucose <
180 mg/dL). In adults, orally administer Forxiga 5 mg (5 mg as dapagliflozin) once daily. If the effect is insufficient, the dose may be increased to 10 mg once daily while carefully observing the pat
Sponsors
Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University
Takagi hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 20-74 years at the time of giving informed consent. 2) Provides written informed consent to participation in the study. 3) HbA1c is 7.0% or higher. 4) BMI is 22 kg/m2 or more.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of body composition (fat content) measured by a body composition analyzer (InBody770K) over the 104-week treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactNoriyuki Sonoda
Graduate School of Medical Sciences, Kyushu University Department of Medicine and Bioregulatory
Outcome results
None listed