Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug in Partially Pancreatectomized Patients Due to Benign Pancreatic Neoplasm.

Conditions
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Partial Pancreatectomy Due to Benign Pancreatic Neoplasm

Intervention / Treatment
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* Procedure: Autologous islet transplantation
* Drug: Oral anti-diabetic drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent distal pancreatectomy for pathologic diagnosis of pancreatic mass Exclusion Criteria: Prior history of diabetes mellitus Patients whose fasting, post-load (75g OGTT) glucose or HbA1c level meet ADA diagnostic criteria Patients who refused to participate the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous islet transplantation<br>Autologous islet transplantation arm: autologous islet transplantation | Procedure: Autologous islet transplantation<br>* 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.<br>|
| Active Comparator: Oral anti-diabetic drugs<br>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<br>* Metformin on the diagnosis of postoperative diabetes mellitus. Starting dose of 500mg per day and dose adjustment as needed to control blood glucose. Vildagliptin added on the insufficient glycemic control with monotherapy. Starting dose of 50mg per day and dose adjustment as needed to control blood glucose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autologous islet transplantation, partial pancreatectomy, pancreatogenic diabetes