UMIN ID: UMIN000045508
Registered date:17/09/2021
Clinical study of ileal bile acid transporter inhibitor on changes in bowel movements and various metabolic markers in type 2 diabetic patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 diabetes mellitus |
| Date of first enrollment | 2018/10/22 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 10mg elobixibat treatment for 12 weeks |
Outcome(s)
| Primary Outcome | Bowel movements (frequency of bowel movements, Bristol Scale) |
|---|---|
| Secondary Outcome | Blood glucose,HbA1c,LDL,HDL,triglyceride,fatty acid fraction,AST,ALT,gammaGTP,Total bile acid,TSH,FT3,FT4,CRP,UA, Ferritin,body weight |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Pregnant or lactating women Patient with intestinal obstruction due to tumor or hernia etc. |
Related Information
| Primary Sponsor | Kurume University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | none |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Satoko Yoshinobu |
| Address | 67 Asahi-machi, Kurume city Fukuoka, JAPAN Japan 8300011 |
| Telephone | 0942317563 |
| yoshinobu_satoko@med.kurume-u.ac.jp | |
| Affiliation | Kurume University School of Medicine Department of Internal Medicine, Division of Endocrinology and Metabolism |
| scientific contact | |
| Name | Satoko Yoshinobu |
| Address | 67 Asahi-machi, Kurume city Fukuoka, JAPAN Japan |
| Telephone | 0942317563 |
| yoshinobu_satoko@med.kurume-u.ac.jp | |
| Affiliation | Kurume University School of Medicine Department of Internal Medicine, Division of Endocrinology and Metabolism |