Type 2 diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Graduate School of Medicine, Juntendo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Diagnosed with type 2 diabetes. 2)Patients who have not reached the glycemic control targets specified in the Diabetes Treatment Guide 2024-2025, despite treatment with diet and exercise therapy or treatment with diabetes medications in addition to diet and exercise therapy for at least 3 months (12 weeks) and are scheduled to receive tofogliflozin hydrate tablets. 3)Patients who have not started a new or changed (increased) dose of any drug, including diabetes medications, for at least 8 weeks prior to obtaining consent. 4)The applicant's age at the time of obtaining consent is at least 18 years old and less than 80 years old. 5)Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes or secondary diabetes. 2.Inferior glycemic control(HbA1c(NGSP) > 10%). 3.A history of cerebrovascular disease. 4.Dementia. 5.Severe hepatic dysfunction(100 IU/L < AST). 6.Moderate or severe heart failure (stage III or higher by NYHA/New York Heart Association classification). 7.Urinary tract or genital tract infections. 8.Pregnant, lactating, possibly pregnant or planning to become pregnant. 9.Malignant tumors or with a history of malignant tumors (however, those who have not received treatment for it and have no evidence of recurrence, and those who can be judged not to recur during the study period may be eligible). 10.Contraindications to tofogliflozin. 11.Other patients deemed by the physician to be inappropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cerebral waste clearance indexes by brain MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in brain volume Changes in diffusion MRI quantitative values Percentage change of the following and correlation between the percentage change and each indicator Cognitive function (MMSE, MoCA-J, Trail Making TesT) Physiological examination (blood pressure, weight, body composition, etc.) Blood test indices (HbA1c, glucose, lipids, liver function, etc.) | — |
Countries
Japan
Contacts
Public ContactHideyoshi Kaga
Graduate School of Medicine, Juntendo University Department of Metabolism & Endocrinology
Outcome results
None listed