UMIN ID: UMIN000013048
Registered date:03/02/2014
The study for efficacy of teneligliptin in non-alcoholic fatty liver disease (NAFLD) with type 2 diabetes mellitus
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | non-alcoholic fatty liver disease/type 2 diabetes mellitus |
| Date of first enrollment | 2014/02/03 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | administration of teneligliptin with diet and exercise therapy diet and exercise therapy only (and administration of glimepiride as needed) |
Outcome(s)
| Primary Outcome | improvement in liver stiffness |
|---|---|
| Secondary Outcome | improvement in physical findings and laboratory data |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) intake more than 20g/day of ethanol 2) HBsAg and/or HCV Ab positive 3) history of hepatic disease, such as autoimmune liver disease, hemochromatosis and Wilson's disease 4) history of diabetes ketosis and/or diabetic coma 5) during pregnancy |
Related Information
| Primary Sponsor | Sapporo Kosei General Hospital, Department of Hepatology |
|---|---|
| Secondary Sponsor | Kyoto Prefectural University of Medicine, Department of endocrinology and metabolism |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tomoaki Nakajima |
| Address | Kita 3 Higashi 8-5, Chuo-ku, Sapporo, Japan Japan |
| Telephone | 011-261-5331 |
| t.nakajima@ja-hokkaidoukouseiren.or.jp | |
| Affiliation | Sapporo Kosei General Hospital Department of hepatology |
| scientific contact | |
| Name | Tomoaki Nakajima |
| Address | Kita 3 Higashi 8-5, Chuo-ku, Sapporo, Japan Japan |
| Telephone | 011-261-5331 |
| t.nakajima@ja-hokkaidoukouseiren.or.jp | |
| Affiliation | Sapporo Kosei General Hospital Department of hepatology |