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Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

Plain-language guide to NCT07540975: not phased randomized trial of Insulin (regular human), pancreatitis (after the acute phase), 290 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07540975
Phase
not phased
Status
not yet recruiting
Start
2026-05-18
Completion (planned or actual)
2029-12-31
Participants
290 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Postoperative Hyperglycemia; Pancreatectomy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Insulin (regular human) for pancreatitis (after the acute phase).

It had two arms (groups): No Insulin Infusion Group (experimental) and Standard Insulin Infusion Group (active comparator).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 290 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: patients diagnosed with pancreatic adenocarcinoma; patients undergoing total pancreatectomy; patients undergoing hepatopancreatoduodenectomy (hpd) or with a history of prior hepatectomy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the pancreatitis (after the acute phase) participants stayed in one arm throughout.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2026-05-18 with completion listed for 2029-12-31.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

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).

It also tracked 7 secondary outcomes, for example Mean Blood Glucose Level on Postoperative Day 0, Mean Blood Glucose Level on Postoperative Day 1, Mean Blood Glucose Level on Postoperative Day 2, Mean Blood Glucose Level on Postoperative Day 3, Postoperative Blood Glucose Variability and Incidence of Hypoglycemia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 290 people with pancreatitis (after the acute phase).

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Pancreatitis (after the acute phase) research.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.