Pancreatectomy; HyperglycemiaNCT04409171
Glucose Metabolism After Partial Pancreatectomy
An observational study of Pancreatectomy; Hyperglycemia and Diabete Mellitus, run by Seoul National University Hospital.
Trial summary
This is a single center observational study to assess alteration of glucose metabolism after pancreatectomy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreatectomy; Hyperglycemia, Diabete Mellitus
- What is being tested?
- oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 31 Jan 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients receiving partial pancreatectomy
Who may be able to join
- partial pancreatectomy
Who cannot join
- total pancreatectomy
- incomplete testing
- follow-up loss
- death within 1 year
About this study
Official title: Alteration of Glucose Metabolism After Partial Pancreatectomy Assessed With Biochemical Markers :A Single Center Prospective Observational Study
This is a single center observational study to assess alteration of glucose metabolism after pancreatectomy.
Read the detailed description
Biochemical markers of glucose metabolism including oral glucose tolerance tests, fasting blood glucose, insulin, glucagon and HbA1c were performed on patients receiving pancreatectomy (pancreaticoduodenectomy and distal pancreatectomy). Tests were done preoperatively, postoperatively at 3 months, and at 1 year. The primary endpoints were the incidence and risk factors of new-onset and worsened DM after each type of pancreatectomy.
- Conditions
- Pancreatectomy; Hyperglycemia, Diabete Mellitus
- Being tested
- oral glucose tolerance test
- Keywords
- Pancreatectomy, Diabetes Mellitus, pancreaticoduodenectomy
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glucose tolerance testDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| PD | pancreaticoduodenectomy Receives: Diagnostic Test: oral glucose tolerance test | |
| DP | distal pancreatectomy Receives: Diagnostic Test: oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence & risk factors of new-onset DM
incidence \& risk factors of new onset DM after pancreatectomy
Measured: at 1 year
incidence & risk factors of worsened DM
incidence \& risk factors of worsened DM after pancreatectomy
Measured: at 1 year
Secondary outcomes (1)
characteristics of new-onset and worsened DM
changes of glucose metabolism during study period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Sep 2015
- Primary completion31 Dec 2018
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatectomy; HyperglycemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoo-Seok Yoon, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409171
- Sponsor's protocol ID
- SNUBH-GS-HBP6
- Status last verified
- May 2020
- First submitted
- 26 May 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans of sharing IPD
Publications
Lee BW, Kang HW, Heo JS, Choi SH, Kim SY, Min YK, Chung JH, Lee MK, Lee MS, Kim KW. Insulin secretory defect plays a major role in the development of diabetes in patients with distal pancreatectomy. Metabolism. 2006 Jan;55(1):135-41. doi: 10.1016/j.metabol.2005.08.005.
PubMed 16324932Hwang HK, Park J, Choi SH, Kang CM, Lee WJ. Predicting new-onset diabetes after minimally invasive subtotal distal pancreatectomy in benign and borderline malignant lesions of the pancreas. Medicine (Baltimore). 2017 Dec;96(51):e9404. doi: 10.1097/MD.0000000000009404.
PubMed 29390555
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration of Glucose Metabolism After Partial Pancreatectomy Assessed With Biochemical Markers :A Single Center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04409171
- Acronym / sponsor ID
- SNUBH-GS-HBP6
- Conditions
- Pancreatectomy; Hyperglycemia, Diabete Mellitus
- Keywords
- Pancreatectomy, Diabetes Mellitus, pancreaticoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 1 Jun 2020 (actual)
- 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.
This is a single center observational study to assess alteration of glucose metabolism after pancreatectomy.
Detailed description
Biochemical markers of glucose metabolism including oral glucose tolerance tests, fasting blood glucose, insulin, glucagon and HbA1c were performed on patients receiving pancreatectomy (pancreaticoduodenectomy and distal pancreatectomy). Tests were done preoperatively, postoperatively at 3 months, and at 1 year. The primary endpoints were the incidence and risk factors of new-onset and worsened DM after each type of pancreatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD | – | Diagnostic Test: oral glucose tolerance testpancreaticoduodenectomy |
| DP | – | Diagnostic Test: oral glucose tolerance testdistal pancreatectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients receiving partial pancreatectomy
Key inclusion criteria (1 listed)
- partial pancreatectomy
Key exclusion criteria (4 listed)
- total pancreatectomy
- incomplete testing
- follow-up loss
- death within 1 year
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 |
|---|---|---|
| oral glucose tolerance test | Diagnostic test | DP, PD |
Primary outcome
incidence & risk factors of new-onset DM
Time frame: at 1 year
incidence \& risk factors of new onset DM after pancreatectomy
incidence & risk factors of worsened DM
Time frame: at 1 year
incidence \& risk factors of worsened DM after pancreatectomy
1 secondary outcome
characteristics of new-onset and worsened DM
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Background: PubMed 16324932Lee BW, Kang HW, Heo JS, Choi SH, Kim SY, Min YK, Chung JH, Lee MK, Lee MS, Kim KW. Insulin secretory defect plays a major role in the development of diabetes in patients with distal pancreatectomy. Metabolism. 2006 Jan;55(1):135-41. doi: 10.1016/j.metabol.2005.08.005.
- Background: PubMed 29390555Hwang HK, Park J, Choi SH, Kang CM, Lee WJ. Predicting new-onset diabetes after minimally invasive subtotal distal pancreatectomy in benign and borderline malignant lesions of the pancreas. Medicine (Baltimore). 2017 Dec;96(51):e9404. doi: 10.1097/MD.0000000000009404.
- Individual participant dataSharing planned: No. There are no plans of sharing IPD
Related trials for Pancreatectomy; Hyperglycemia
Not yet recruiting
Postoperative Insulin Intervention After Pancreatectomy in nDM Patients
Postoperative Hyperglycemia, Pancreatectomy
Active, not recruitingObservational study
A Prospective Observational Study of TPIAT
Pancreatitis, Chronic, Pancreatectomy; Hyperglycemia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatectomy; Hyperglycemia and Diabete Mellitus, run by Seoul National University Hospital.
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 4 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: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence & risk factors of new-onset DM (time frame: at 1 year). The study lists 2 primary outcomes in all. 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 NCT04409171, which also lists 2 linked publications.
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 1 Jun 2020.