Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

November 17, 2015 updated by: Kyong Soo Park, Seoul National University Hospital

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

  • 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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

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 day and dose adjustment as needed to control blood glucose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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).
preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
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.
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).
preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Adverse effects
Time Frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Novartis
Ministry of Health & Welfare, Korea

Investigators

  • Principal Investigator: Kyong Soo Park, Seoul National University Hospital

Publications and helpful links

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

General Publications

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 Major Dates

Study Start

May 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (ESTIMATE)

August 14, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHUH_AIT_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Partial Pancreatectomy Due to Benign Pancreatic Neoplasm

Clinical Trials on Autologous islet transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe