UMIN ID: UMIN000054715
Registered date:20/06/2024
Effects of Imeglimin on Muscle Strength and Mass in Diabetic Patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Type 2 diabetes |
| Date of first enrollment | 2022/03/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | The primary endpoint was the percent change in quadriceps strength and grip strength from baseline (week 0) to week 24 in the imeglimine and control groups. |
|---|---|
| Secondary Outcome | Secondary endpoints were changes in total body muscle mass and total body fat mass from week 0 to week 24 in the imeglimine and control groups. |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients with type 1 diabetes, patients requiring emergency response or drug adjustment (such as those with extremely poor diabetes control, repeated severe hypoglycemia, patients before and after surgery, acute infection, diabetic gangrene, and severe trauma), and patients with expected edema (including those with severe heart failure and renal failure) |
Related Information
| Primary Sponsor | St. Marianna University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | St. Marianna University School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Takeshi Oyanagi |
| Address | 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan Japan 216-8511 |
| Telephone | 044-977-8111 |
| takeshi.oyanagi@marianna-u.ac.jp | |
| Affiliation | St. Marianna University School of Medicine Department of Internal Medicine, Division of Metabolism and Endocrinology |
| scientific contact | |
| Name | Shin Kawanabe |
| Address | 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan Japan |
| Telephone | 044-977-8111 |
| s2kawanabe@marianna-u.ac.jp | |
| Affiliation | St. Marianna University School of Medicine Department of Internal Medicine, Division of Metabolism and Endocrinology |