The Effect of SGLT2 inhibitor Tofogliflozin to Quality of Life of Patients with Type 2 Diabetes Mellitus Research

Not Applicable

• Conditions: Type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000031867
• Lead Sponsor: HO Kyoto Medical Center, Diabetes Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients using pharmaceuticals to treat diabetes mellitus other than DPP-4 inhibitor and sulfonyl urea and insulin (including GLP-1 receptor agonist) for 3 month or more prior to the moment starting tofogliflozin. 2) Patients with the serum creatinine levels of 2.0 mg/dl or more. 3) Patients with hypothyroidism. 4) Patients with hyperthyroidism. 5) Patients with BMI less than 18.5 kg/m2, or 40 kg/m2 or more. 6) Patients who have allergy to tofogliflozin. 7) Patients with severe ketosiss, diabetic coma or impending diabetic coma. 8) Patinets with severe infection, in perioperative period, or with severe trauma. 9) Patients to whom participating this study is considered to be inappropriate for any reason.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the diabetes treatment satisfaction measured by DTSQ after 12 month of adding tofogliflozin.

Secondary Outcome Measures

Name	Time	Method
1) Change in the diabetes treatment satisfaction measured by DTSQ after 3 month of adding tofogliflozin. 2) Change in the eating behavior survey, the food frequency survey, the QOL self-administered questionnaire, and International Prostate Symptom Score. 3) Correlation between the change in the quality of life and the glycemic control, the body weight and the body composition. 4) Correlation between the change in the eating behavior and the glycemic control, the body weight and the body composition. 5) Correlation between the change in the energy intake and the glycemic control, the body weight and the body composition. 6) Change in the markers of the glycemic control, blood sample analysis, body composition, capability to secrete insulin, special blood sample analysis, urine sample analysis and medication adherence.