Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous islet transplantation | Experimental | Autologous islet transplantation arm: autologous islet transplantation |
|
| Oral anti-diabetic drugs | Active Comparator | Metformin (starting from 500mg qd with dose adjustment thereafter) with or without vildagliptin (starting from 50mg qd with dose adjustment thereafter) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous islet transplantation | Procedure | Islet was isolated from the normal part of resected pancreas with modified Ricordi method. After purification, the islets were infused into the liver through percutaneous transhepatic portal vein catheterization. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of insulin secretory function | Insulin secretion was evaluated by calculating insulinogenic index (Δ insulin30min (μIU/ml)/Δglucose30min (mmol/L) during 75g-OGTT) and homeostasis model assessment for beta cell function (HOMA-B). | preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of glucose tolerance | Glucose tolerance was evaluated by HbA1c (%), 1,5-anhydroglucitol (ug/ml), and area under the curve of glucose (75g OGTT, mg/dl*min). | preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. |
| Incidence of postoperative diabetes mellitus |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyong Soo Park | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24978858 | Derived | Yoon JW, Jung HS, Jang JY, Kim MJ, Kim JH, Ohn JH, Kim JH, Lee HM, Kim HC, Lee KB, Choi SA, Kim SW, Park KS. Improved Insulin Secretion by Autologous Islet Transplantation, Compared to Oral Antidiabetic Agents, After Distal Pancreatectomy. Cell Transplant. 2015;24(8):1615-26. doi: 10.3727/096368914X682440. Epub 2014 Jun 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oral anti-diabetic drugs | Drug |
|
|
| preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. |
| Changes of insulin resistance | Insulin resistance was evaluated by homeostasis model assessment for insulin resistance (HOMA-IR). | preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. |
| Adverse effects | preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. |