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Insulin Therapy for Postreperfusion Hyperglycemia

Plain-language guide to NCT03152890: phase 4 interventional trial of Insulin (regular human), 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03152890
Phase
phase 4
Status
status unknown
Start
2017-05-15
Completion (planned or actual)
2024-12-15
Participants
20 (estimated)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Hyperglycaemia (Diabetic); Liver Transplantation
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

Glycemic control during liver transplantation is challenging especially after reperfusion of the liver graft.

It had 1 arm (groups): Study group (experimental).

The registry classes the interventions as drug.

More on the Plan

Hyperglycemia is common during liver transplantation ,especially after graft reperfusion.

Response to insulin is frequently unpredictable during postreperfusion period with no consensus or guidelines on glycemic control.

In the retrospective study, adult liver recipients (\>18 years old) who underwent liver transplantation between 2004 and 2016 are reviewed.

Delta glucose is the primary outcome variable defined as the difference in blood glucose levels before and after insulin administration.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 19 years with no upper age limit.

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

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: pediatric patients.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-05-15 with completion listed for 2024-12-15.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change of blood glucose level 20 minutes after insulin administration (time frame: 20 minutes after insulin administration).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin (regular human) in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.

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.