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Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

Primary Purpose

Partial Pancreatectomy Due to Benign Pancreatic Neoplasm

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous islet transplantation
Oral anti-diabetic drugs
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Pancreatectomy Due to Benign Pancreatic Neoplasm focused on measuring autologous islet transplantation, partial pancreatectomy, pancreatogenic diabetes

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Autologous islet transplantation

Oral anti-diabetic drugs

Arm Description

Autologous islet transplantation arm: autologous islet transplantation

Metformin (starting from 500mg qd with dose adjustment thereafter) with or without vildagliptin (starting from 50mg qd with dose adjustment thereafter)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Incidence of postoperative diabetes mellitus
Changes of insulin resistance
Insulin resistance was evaluated by homeostasis model assessment for insulin resistance (HOMA-IR).
Adverse effects

Full Information

First Posted
August 7, 2013
Last Updated
November 17, 2015
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea, Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01922492
Brief Title
Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.
Official Title
Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug in Partially Pancreatectomized Patients Due to Benign Pancreatic Neoplasm.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea, Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Pancreatectomy Due to Benign Pancreatic Neoplasm
Keywords
autologous islet transplantation, partial pancreatectomy, pancreatogenic diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous islet transplantation
Arm Type
Experimental
Arm Description
Autologous islet transplantation arm: autologous islet transplantation
Arm Title
Oral anti-diabetic drugs
Arm Type
Active Comparator
Arm Description
Metformin (starting from 500mg qd with dose adjustment thereafter) with or without vildagliptin (starting from 50mg qd with dose adjustment thereafter)
Intervention Type
Procedure
Intervention Name(s)
Autologous islet transplantation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral anti-diabetic drugs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of insulin secretory function
Description
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).
Time Frame
preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Secondary Outcome Measure Information:
Title
Changes of glucose tolerance
Description
Glucose tolerance was evaluated by HbA1c (%), 1,5-anhydroglucitol (ug/ml), and area under the curve of glucose (75g OGTT, mg/dl*min).
Time Frame
preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Title
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.
Title
Changes of insulin resistance
Description
Insulin resistance was evaluated by homeostasis model assessment for insulin resistance (HOMA-IR).
Time Frame
preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Title
Adverse effects
Time Frame
preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyong Soo Park
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24978858
Citation
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.
Results Reference
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Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

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