UMIN ID: UMIN000054359
Registered date:10/05/2024
A Cross-Sectional Study on the Serum Metal Levels in Patients with Type 2 Diabetes Treated with Metformin
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 diaebtes |
| Date of first enrollment | 2022/07/20 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Comparing serum copper levels in patients with type 2 diabetes with and without metformin. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Patients currently taking iron supplements. 2. Patients currently taking zinc supplements. 3. Patients currently taking vitamin B12 supplements. 4. Patients currently taking folic acid supplements. 5. Patients with anemia. 6. Patients who have undergone gastric, duodenal, or small intestine resection (excluding those who have undergone endoscopic mucosal resection or submucosal dissection). 7. Patients who are pregnant or breastfeeding. 8. Patients with malabsorption issues (e.g., chronic pancreatitis, inflammatory bowel disease, malabsorption syndrome). 9. Patients with renal dysfunction (eGFR < 30 mL/min/1.73m2). 10. Patients with cirrhosis. 11. Patients currently undergoing treatment for malignant tumors. 12. Other patients deemed inappropriate for the study by the investigator. |
Related Information
| Primary Sponsor | Kobe University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Manpei Suzuki Diabetes Foundation |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Natsu Otowa-Suematsu |
| Address | 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan Japan 650-0017 |
| Telephone | 078-382-5861 |
| suematsu@med.kobe-u.ac.jp | |
| Affiliation | Kobe University Graduate School of Medicine Division of Diabetes and Endocrinology |
| scientific contact | |
| Name | Kazuhiko Sakaguchi |
| Address | 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan Japan |
| Telephone | 078-382-5861 |
| kzhkskgc@med.kobe-u.ac.jp | |
| Affiliation | Kobe University Graduate School of Medicine Division of Diabetes and Endocrinology |