Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

Not Applicable

• Conditions: Partial Pancreatectomy Due to Benign Pancreatic Neoplasm
• Interventions: Procedure: Autologous islet transplantation; Drug: Oral anti-diabetic drugs

• Registration Number: NCT01922492
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2013-08-07
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-14
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-20
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous islet transplantation	Autologous islet transplantation	Autologous islet transplantation arm: autologous islet transplantation
Oral anti-diabetic drugs	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)

Primary Outcome Measures

Name	Time	Method
Changes of insulin secretory function	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

Name	Time	Method
Changes of insulin resistance	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).
Changes of glucose tolerance	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).
Incidence of postoperative diabetes mellitus	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of