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Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

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ClinicalTrials.gov Identifier: NCT01922492
Recruitment Status : Unknown
Verified November 2015 by Kyong Soo Park, Seoul National University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 14, 2013
Last Update Posted : November 20, 2015
Sponsor:
Collaborators:
Ministry of Health & Welfare, Korea
Novartis
Information provided by (Responsible Party):
Kyong Soo Park, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Partial Pancreatectomy Due to Benign Pancreatic Neoplasm Procedure: Autologous islet transplantation Drug: Oral anti-diabetic drugs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug in Partially Pancreatectomized Patients Due to Benign Pancreatic Neoplasm.
Study Start Date : May 2008
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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. ]
  3. 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).

  4. Adverse effects [ Time Frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop. ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922492


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health & Welfare, Korea
Novartis
Investigators
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Principal Investigator: Kyong Soo Park Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kyong Soo Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01922492     History of Changes
Other Study ID Numbers: SHUH_AIT_1
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Kyong Soo Park, Seoul National University Hospital:
autologous islet transplantation
partial pancreatectomy
pancreatogenic diabetes
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs