Partial Pancreatectomy Due to Benign Pancreatic NeoplasmNCT01922492
Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug.
A study testing Autologous islet transplantation and Oral anti-diabetic drugs in people with Partial Pancreatectomy Due to Benign Pancreatic Neoplasm, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Partial Pancreatectomy Due to Benign Pancreatic Neoplasm
- What is being tested?
- Autologous islet transplantation and Oral anti-diabetic drugs
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2008to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent distal pancreatectomy for pathologic diagnosis of pancreatic mass
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug in Partially Pancreatectomized Patients Due to Benign Pancreatic Neoplasm.
- 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.
- Being tested
- Autologous islet transplantation, Oral anti-diabetic drugs
- Keywords
- autologous islet transplantation, partial pancreatectomy, pancreatogenic diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous islet transplantationProcedure or surgery
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 drugsDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous islet transplantation | Experimental | Autologous islet transplantation arm: autologous islet transplantation Receives: Procedure: Autologous islet transplantation |
| Oral anti-diabetic drugs | Active comparator | Metformin (starting from 500mg qd with dose adjustment thereafter) with or without vildagliptin (starting from 50mg qd with dose adjustment thereafter) Receives: Drug: Oral anti-diabetic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of insulin secretory function
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).
Measured: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Secondary outcomes (4)
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).
Measured: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Incidence of postoperative diabetes mellitus
Measured: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Changes of insulin resistance
Insulin resistance was evaluated by homeostasis model assessment for insulin resistance (HOMA-IR).
Measured: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Adverse effects
Measured: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startMay 2008
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial Pancreatectomy Due to Benign Pancreatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Novartis
- Responsible party
- Principal investigator, Kyong Soo Park, Seoul National University Hospital
- Investigators
- Kyong Soo Park, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922492
- Sponsor's protocol ID
- SHUH_AIT_1
- Status last verified
- Nov 2015
- First submitted
- 7 Aug 2013
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24978858
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug in Partially Pancreatectomized Patients Due to Benign Pancreatic Neoplasm.
- ClinicalTrials.gov ID
- NCT01922492
- Acronym / sponsor ID
- SHUH_AIT_1
- Keywords
- autologous islet transplantation, partial pancreatectomy, pancreatogenic diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea, Novartis
- Study start
- May 2008
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous islet transplantation | Experimental | Procedure: Autologous islet transplantationAutologous islet transplantation arm: autologous islet transplantation |
| Oral anti-diabetic drugs | Active comparator | Drug: Oral anti-diabetic drugsMetformin (starting from 500mg qd with dose adjustment thereafter) with or without vildagliptin (starting from 50mg qd with dose adjustment thereafter) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent distal pancreatectomy for pathologic diagnosis of pancreatic mass
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous islet transplantationIslet 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. | Procedure or surgery | Autologous islet transplantation |
| 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. | Drug | Oral anti-diabetic drugs |
Primary outcome
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).
4 secondary outcomes
Changes of glucose tolerance
Time frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
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.
Changes of insulin resistance
Time frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Adverse effects
Time frame: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 24978858Yoon 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyong Soo Park principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous islet transplantation and Oral anti-diabetic drugs in people with Partial Pancreatectomy Due to Benign Pancreatic Neoplasm, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.