Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.
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|ClinicalTrials.gov Identifier: NCT01922492|
Recruitment Status : Unknown
Verified November 2015 by Kyong Soo Park, Seoul National University Hospital.
Recruitment status was: Active, not recruiting
First Posted : August 14, 2013
Last Update Posted : November 20, 2015
- Effects of autologous islet transplantation were compared to those of oral anti-diabetic drugs after distal pancreatectomy.
- The primary interest is a insulin-secretory function after the surgery in two intervention groups.
|Condition or disease||Intervention/treatment||Phase|
|Partial Pancreatectomy Due to Benign Pancreatic Neoplasm||Procedure: Autologous islet transplantation Drug: Oral anti-diabetic drugs||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug in Partially Pancreatectomized Patients Due to Benign Pancreatic Neoplasm.|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Autologous islet transplantation
Autologous islet transplantation arm: autologous islet transplantation
Procedure: Autologous islet transplantation
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.
Active Comparator: Oral anti-diabetic drugs
Metformin (starting from 500mg qd with dose adjustment thereafter) with or without vildagliptin (starting from 50mg qd with dose adjustment thereafter)
Drug: Oral anti-diabetic drugs
- Changes of insulin secretory function [ Time Frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. ]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).
- Changes of glucose tolerance [ Time Frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. ]Glucose tolerance was evaluated by HbA1c (%), 1,5-anhydroglucitol (ug/ml), and area under the curve of glucose (75g OGTT, mg/dl*min).
- Incidence of postoperative diabetes mellitus [ Time Frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. ]
- Changes of insulin resistance [ Time Frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. ]Insulin resistance was evaluated by homeostasis model assessment for insulin resistance (HOMA-IR).
- Adverse effects [ Time Frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922492
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Kyong Soo Park||Seoul National University Hospital|