Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.
NCT ID: NCT01922492
Last Updated: 2015-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
28 participants
INTERVENTIONAL
2008-05-31
2017-12-31
Brief Summary
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* The primary interest is a insulin-secretory function after the surgery in two intervention groups.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Autologous islet transplantation
Autologous islet transplantation arm: autologous islet transplantation
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.
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)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients whose fasting, post-load (75g OGTT) glucose or HbA1c level meet ADA diagnostic criteria
* Patients who refused to participate the study
20 Years
80 Years
ALL
No
Sponsors
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Ministry of Health & Welfare, Korea
OTHER_GOV
Novartis
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Kyong Soo Park
Professor
Principal Investigators
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Kyong Soo Park
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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SHUH_AIT_1
Identifier Type: -
Identifier Source: org_study_id