UMIN ID: UMIN000056120
Registered date:13/11/2024
Study of the effect of diabetes medications on alcohol consumption and liver fat content in patients with type 2 diabetes mellitus complicated by fatty liver disease
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 diabetes mellitus complicated by fatty liver |
| Date of first enrollment | 2024/06/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Type 2 diabetes patients who start on tirzepatide (SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, and metformin are also included in the study population in the same process) |
Outcome(s)
| Primary Outcome | Change in liver fat content, HbA1c, and BMI at 36 weeks from baseline |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 100years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Alcohol consumption exceeding 20g for women or 30g for men per day. Pregnant women. Contraindication to MRI. BMI less than 18 kgm2. SGLT2 inhibitors were excluded if they were started within 1 year of study entry. Other diabetes medications were excluded for those starting within 8 weeks of study entry. Severe renal or hepatic disease. Other chronic liver disease. |
Related Information
| Primary Sponsor | JCHO Tokyo Yamate Medical Centre |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Akihisa Hidaka |
| Address | 3-22-1 Hyakunin-cho, Shinjuku-ku Tokyo, Japan Japan 169-0073 |
| Telephone | 03-3364-0251 |
| akihisahidaka@gmail.com | |
| Affiliation | JCHO Tokyo Yamate Medical Centre Department of Diabetes and Endocrinology |
| scientific contact | |
| Name | Akihisa Hidaka |
| Address | 3-22-1 Hyakunin-cho, Shinjuku-ku Tokyo, Japan Japan |
| Telephone | 03-3364-0251 |
| akihisahidaka@gmail.com | |
| Affiliation | JCHO Tokyo Yamate Medical Centre Department of Diabetes and Endocrinology |