Effect Of Islet Autotransplantation Compared To Oral Antidiabetic Drug.

Study Overview

Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

* 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.

N/A

Partial Pancreatectomy Due to Benign Pancreatic Neoplasm

PROCEDURE: Autologous islet transplantation
DRUG: Oral anti-diabetic drugs

SHUH_AIT_1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-08-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-11-17
First Submitted that Met QC Criteria 2013-08-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-11-20
First Posted (ESTIMATED) 2013-08-14	Results First Posted N/A	Last Verified 2015-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
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 * 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 d

Participant Group/Arm

Intervention/Treatment

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

* 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 d

Primary Outcome Measures	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	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.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

Patients who underwent distal pancreatectomy for pathologic diagnosis of pancreatic mass

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Ministry of Health & Welfare, Korea
Novartis

Investigators

PRINCIPAL_INVESTIGATOR: Kyong Soo Park, Seoul National University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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Resources

Patients

Caregivers

Clinical Trial Record