Postoperative HyperglycemiaNCT07540975
Postoperative Insulin Intervention After Pancreatectomy in nDM Patients
A study testing Insulin Infusion and No Insulin Infusion (Standard Monitoring Only) in people with Postoperative Hyperglycemia and Pancreatectomy, run by Dae Wook Hwang at 1 site in South Korea.
Trial summary
The goal of this randomized non-inferiority clinical trial is to evaluate whether routine postoperative insulin infusion can be safely omitted in preoperative non-diabetic adult patients undergoing pancreatectomy for periampullary or pancreatic tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Hyperglycemia, Pancreatectomy
- What is being tested?
- Insulin Infusion and No Insulin Infusion (Standard Monitoring Only)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 May 2026to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years
- Patients without a prior diagnosis of diabetes mellitus
- Patients scheduled to undergo pancreatectomy for periampullary tumors or pancreatic tumors
- Ability to understand the study and provide written informed consent
Who cannot join
- Patients diagnosed with pancreatic adenocarcinoma
- Patients undergoing total pancreatectomy
- Patients undergoing hepatopancreatoduodenectomy (HPD) or with a history of prior hepatectomy
- Patients with severe comorbidities (e.g., liver cirrhosis, chronic kidney disease, or heart failure)
- Patients currently enrolled in another clinical trial that may interfere with this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Asan medical center
Seoul, 05505
Seo Hyun Kim, Study Coordinator, +82-2-3010-8667, ksh6136@amc.seoul.kr
About this study
Official title: Effects of Insulin Intervention After Pancreatectomy in Preoperative Non-diabetic Patients : Randomized Non-inferiority Clinical Trial
The goal of this randomized non-inferiority clinical trial is to evaluate whether routine postoperative insulin infusion can be safely omitted in preoperative non-diabetic adult patients undergoing pancreatectomy for periampullary or pancreatic tumors. The primary purpose is to determine whether withholding insulin infusion provides comparable glycemic control while reducing treatment-related burden and adverse events.
The main questions it aims to answer are:
Read more
- Does omission of postoperative insulin infusion result in non-inferior mean blood glucose levels through postoperative day (POD) 3 compared to standard insulin infusion?
- Does omission of insulin infusion reduce the incidence of hypoglycemia without increasing postoperative complications, including surgical site infection within 3 months?
Researchers will compare a no-insulin infusion group (intervention arm) with a standard insulin infusion group (control arm) to determine whether avoiding routine insulin infusion maintains comparable glycemic control while improving safety and patient comfort.
Participants will:
- Undergo pancreatectomy and be randomly assigned (1:1) to either receive standard insulin infusion or no routine insulin infusion postoperatively
- Have blood glucose monitored using intermittent testing and continuous glucose monitoring (flash glucose monitoring system)
- Receive protocol-based glycemic management, including rescue insulin if hyperglycemia occurs or discontinuation if hypoglycemia develops
- Be followed for up to 3 months postoperatively to assess glycemic outcomes, hypoglycemic events, surgical site infection, and other postoperative complications
- Complete a questionnaire assessing discomfort related to glucose monitoring and insulin administration
This study aims to establish evidence-based postoperative glucose management strategies for non-diabetic patients undergoing pancreatectomy.
- Conditions
- Postoperative Hyperglycemia, Pancreatectomy
- Being tested
- Insulin Infusion, No Insulin Infusion (Standard Monitoring Only)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin InfusionDrug
Continuous intravenous insulin infusion administered postoperatively according to institutional protocol. Blood glucose levels are monitored at regular intervals, and the infusion rate is adjusted to maintain target glucose levels (typically 140-180 mg/dL). Insulin infusion is continued until postoperative day 2 (9 AM) unless discontinued earlier due to hypoglycemia or clinical indication.
No Insulin Infusion (Standard Monitoring Only)Other
Postoperative management without routine insulin infusion. Blood glucose levels are monitored four times daily. If fasting blood glucose exceeds 180 mg/dL for two consecutive days, rescue insulin therapy is initiated according to institutional protocol. All other perioperative care follows standard postoperative management.
| Study group | Role | What they receive |
|---|---|---|
| No Insulin Infusion Group | Experimental | Participants assigned to this group will not receive routine postoperative insulin infusion following pancreatectomy. Blood glucose will be monitored four times daily. If fasting blood glucose exceeds 180 mg/dL for two consecutive days, rescue insulin therapy will be initiated according to institutional protocol. All other perioperative care will follow standard postoperative management. Receives: Other: No Insulin Infusion (Standard Monitoring Only) |
| Standard Insulin Infusion Group | Active comparator | Participants assigned to this group will receive continuous insulin infusion following pancreatectomy according to institutional protocol. Blood glucose will be monitored every 2 hours initially, with adjustment of insulin infusion rate to maintain target glucose levels (typically 140-180 mg/dL). Insulin infusion will be continued until postoperative day 2 (9 AM), unless discontinued earlier due to hypoglycemia or clinical indication. Receives: Drug: Insulin Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Blood Glucose Level (Average of Daily Mean Values from Postoperative Day 0 to 3)
Measured: From postoperative day 0 through postoperative day 3
Secondary outcomes (7)
Mean Blood Glucose Level on Postoperative Day 0
Measured: Postoperative day 0
Mean Blood Glucose Level on Postoperative Day 1
Measured: Postoperative day 1
Mean Blood Glucose Level on Postoperative Day 2
Measured: Postoperative day 2
Mean Blood Glucose Level on Postoperative Day 3
Measured: Postoperative day 3
Postoperative Blood Glucose Variability
Measured: From postoperative day 0 through postoperative day 3
Incidence of Hypoglycemia
Measured: From postoperative day 0 through postoperative day 3
Incidence of Surgical Site Infection (SSI)
Measured: Within 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start18 May 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HyperglycemiaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dae Wook Hwang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dae Wook Hwang, Asan Medical Center
- Investigators
- Dae Wook Hwang, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540975
- Sponsor's protocol ID
- 2021-1708
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Insulin Intervention After Pancreatectomy in Preoperative Non-diabetic Patients : Randomized Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT07540975
- Acronym / sponsor ID
- 2021-1708
- Conditions
- Postoperative Hyperglycemia, Pancreatectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Dae Wook HwangUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 21 Apr 2026 (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.
The goal of this randomized non-inferiority clinical trial is to evaluate whether routine postoperative insulin infusion can be safely omitted in preoperative non-diabetic adult patients undergoing pancreatectomy for periampullary or pancreatic tumors. The primary purpose is to determine whether withholding insulin infusion provides comparable glycemic control while reducing treatment-related burden and adverse events.
The main questions it aims to answer are:
- Does omission of postoperative insulin infusion result in non-inferior mean blood glucose levels through postoperative day (POD) 3 compared to standard insulin infusion?
- Does omission of insulin infusion reduce the incidence of hypoglycemia without increasing postoperative complications, including surgical site infection within 3 months?
Researchers will compare a no-insulin infusion group (intervention arm) with a standard insulin infusion group (control arm) to determine whether avoiding routine insulin infusion maintains comparable glycemic control while improving safety and patient comfort.
Participants will:
- Undergo pancreatectomy and be randomly assigned (1:1) to either receive standard insulin infusion or no routine insulin infusion postoperatively
- Have blood glucose monitored using intermittent testing and continuous glucose monitoring (flash glucose monitoring system)
- Receive protocol-based glycemic management, including rescue insulin if hyperglycemia occurs or discontinuation if hypoglycemia develops
- Be followed for up to 3 months postoperatively to assess glycemic outcomes, hypoglycemic events, surgical site infection, and other postoperative complications
- Complete a questionnaire assessing discomfort related to glucose monitoring and insulin administration
This study aims to establish evidence-based postoperative glucose management strategies for non-diabetic patients undergoing pancreatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Insulin Infusion Group | Experimental | Other: No Insulin Infusion (Standard Monitoring Only)Participants assigned to this group will not receive routine postoperative insulin infusion following pancreatectomy. Blood glucose will be monitored four times daily. If fasting blood glucose exceeds 180 mg/dL for two consecutive days, rescue insulin therapy will be initiated according to institutional protocol. All other perioperative care will follow standard postoperative management. |
| Standard Insulin Infusion Group | Active comparator | Drug: Insulin InfusionParticipants assigned to this group will receive continuous insulin infusion following pancreatectomy according to institutional protocol. Blood glucose will be monitored every 2 hours initially, with adjustment of insulin infusion rate to maintain target glucose levels (typically 140-180 mg/dL). Insulin infusion will be continued until postoperative day 2 (9 AM), unless discontinued earlier due to hypoglycemia or clinical indication. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 80 years
- Patients without a prior diagnosis of diabetes mellitus
- Patients scheduled to undergo pancreatectomy for periampullary tumors or pancreatic tumors
- Ability to understand the study and provide written informed consent
Key exclusion criteria (5 listed)
- Patients diagnosed with pancreatic adenocarcinoma
- Patients undergoing total pancreatectomy
- Patients undergoing hepatopancreatoduodenectomy (HPD) or with a history of prior hepatectomy
- Patients with severe comorbidities (e.g., liver cirrhosis, chronic kidney disease, or heart failure)
- Patients currently enrolled in another clinical trial that may interfere with this 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 |
|---|---|---|
| Insulin InfusionContinuous intravenous insulin infusion administered postoperatively according to institutional protocol. Blood glucose levels are monitored at regular intervals, and the infusion rate is adjusted to maintain target glucose levels (typically 140-180 mg/dL). Insulin infusion is continued until postoperative day 2 (9 AM) unless discontinued earlier due to hypoglycemia or clinical indication. | Drug | Standard Insulin Infusion Group |
| No Insulin Infusion (Standard Monitoring Only)Postoperative management without routine insulin infusion. Blood glucose levels are monitored four times daily. If fasting blood glucose exceeds 180 mg/dL for two consecutive days, rescue insulin therapy is initiated according to institutional protocol. All other perioperative care follows standard postoperative management. | Other | No Insulin Infusion Group |
Primary outcome
Mean Blood Glucose Level (Average of Daily Mean Values from Postoperative Day 0 to 3)
Time frame: From postoperative day 0 through postoperative day 3
7 secondary outcomes
Mean Blood Glucose Level on Postoperative Day 0
Time frame: Postoperative day 0
Mean Blood Glucose Level on Postoperative Day 1
Time frame: Postoperative day 1
Mean Blood Glucose Level on Postoperative Day 2
Time frame: Postoperative day 2
Mean Blood Glucose Level on Postoperative Day 3
Time frame: Postoperative day 3
Postoperative Blood Glucose Variability
Time frame: From postoperative day 0 through postoperative day 3
Incidence of Hypoglycemia
Time frame: From postoperative day 0 through postoperative day 3
Incidence of Surgical Site Infection (SSI)
Time frame: Within 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Dae Wook Hwang principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin Infusion and No Insulin Infusion (Standard Monitoring Only) in people with Postoperative Hyperglycemia and Pancreatectomy, run by Dae Wook Hwang 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirang Lee, Dr (+81-10-3390-5026, effly5026@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Blood Glucose Level (Average of Daily Mean Values from Postoperative Day 0 to 3) (time frame: From postoperative day 0 through postoperative day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.