Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

N/AUnknownNCT01922492

Seoul National University Hospital28 enrolled

Overview

* 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Partial Pancreatectomy Due to Benign Pancreatic Neoplasm

Interventions

Autologous islet transplantationPROCEDURE

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.

Oral anti-diabetic drugsDRUG

* 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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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).