Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.

Seoul National University

Status: Unknown

Conditions: Partial Pancreatectomy Due to Benign Pancreatic Neoplasm

Treatments: Drug: Oral anti-diabetic drugs; Procedure: Autologous islet transplantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01922492

SHUH_AIT_1

Details and patient eligibility

About

• 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.

Enrollment: 28 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Autologous islet transplantation

Experimental group

Description:

Autologous islet transplantation arm: autologous islet transplantation

Treatment:

Procedure: Autologous islet transplantation

Oral anti-diabetic drugs

Active Comparator group

Description:

Metformin (starting from 500mg qd with dose adjustment thereafter) with or without vildagliptin (starting from 50mg qd with dose adjustment thereafter)

Treatment:

Drug: Oral anti-diabetic drugs