UMIN ID: UMIN000054555
Registered date:03/06/2024
Evaluation of effectiveness of SGLT2 inhibitor on the sleep quality
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 diabetes mellitus |
| Date of first enrollment | 2024/06/05 |
| Target sample size | 82 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | The difference of change of sleep quality between the patients with type 2 diabetes mellitus with/without SGLT2 inhibitor add-on treatment |
|---|---|
| Secondary Outcome | The factors that associate with changes in sleep quality with the use of add-on SGLT2 inhibitors Influence of SGLT2 inhibitor and other antidiabetic drugs on the nocturia |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 85years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients who are taking diuretics Patients with dementia or requiring long-term care, who cannot answer the questionnaire survey by themselves Patients who have added or changed their antidiabetic drugs or insulin injection within the past three months Patients who have had SGLT2 inhibitor within the past six months |
Related Information
| Primary Sponsor | Department of Internal Medicine, Kurume University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yukihiro Inoguchi |
| Address | 67 Asahi-Machi, Kurume, Fukuoka, Japan Japan 830-0011 |
| Telephone | 0942-31-7563 |
| inoguchi_yukihiro@kurume-u.ac.jp | |
| Affiliation | Department of Internal Medicine, Kurume University School of Medicine Division of Endocrinology and Metabolism |
| scientific contact | |
| Name | Yukihiro Inoguchi |
| Address | 67 Asahi-Machi, Kurume, Fukuoka, Japan Japan |
| Telephone | 0942-31-7563 |
| inoguchi_yukihiro@kurume-u.ac.jp | |
| Affiliation | Department of Internal Medicine, Kurume University School of Medicine Division of Endocrinology and Metabolism |