Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

Partial Pancreatectomy Due to Benign Pancreatic Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01922492
• Other study ID #: SHUH_AIT_1
• Status: Active, not recruiting
• Phase: N/A
• First received: August 7, 2013
• Last updated: November 17, 2015
• Start date: May 2008
• Est. completion date: December 2017

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Partial Pancreatectomy Due to Benign Pancreatic Neoplasm

Intervention

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.

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Health & Welfare, Korea, Novartis

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of insulin secretory function	Insulin secretion was evaluated by calculating insulinogenic index (? insulin30min (µIU/ml)/?glucose30min (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.	No
Secondary	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).	preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.	No
Secondary	Incidence of postoperative diabetes mellitus		preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.	No
Secondary	Changes of insulin resistance	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.	No
Secondary	Adverse effects		preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.	Yes