NCT01922492

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

9.6 years

First QC Date

August 7, 2013

Last Update Submit

November 17, 2015

Conditions

Partial Pancreatectomy Due to Benign Pancreatic Neoplasm

Keywords

autologous islet transplantationpartial pancreatectomypancreatogenic diabetes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Changes of glucose tolerance

    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

    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.

Study Arms (2)

Autologous islet transplantation

EXPERIMENTAL

Autologous islet transplantation arm: autologous islet transplantation

Procedure: Autologous islet transplantation

Oral anti-diabetic drugs

ACTIVE COMPARATOR

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

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.

Autologous islet transplantation
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.

Oral anti-diabetic drugs

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent distal pancreatectomy for pathologic diagnosis of pancreatic mass

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 24978858DERIVED

Study Officials

  • Kyong Soo Park

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 14, 2013

Study Start

May 1, 2008

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

KR(1)