Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

What Was Tested

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

It had three arms (groups): Group A: intensive insulin (experimental), Group B: standard insulin (active comparator) and Group C: plasmapheresis (active comparator).

Group C: plasmapheresis.

The registry classes the interventions as device and drug.

More on the Plan

It is the third leading cause of pancreatitis after biliary and alcoholic etiology.

Hypertriglyceridemia can be caused by primary causes, lipid metabolism disorders and secondary causes.

Who Took Part

200 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Onset of abdominal pain within \<=48h before admission. Moderate severe or severe Acute Pancreatitis according to Atlanta criteria. Except for other AP causes, such as cholelithiasis, alcohol, drugs and so on.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: other etiologies other than hyperlipidemia leading to ap; at the same time combined with other etiologies of ap; appear difficult to reverse respiratory failure, severe systemic circulatory failure, coma and other the endangered symptoms, patients expected to die within 24hours.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

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

It started in 2018-06-06 with completion listed for 2020-03-08.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): triglyceride levels (time frame: From admition to hospital discharge, an average of 2 months).

It also tracked 5 secondary outcomes, for example cytokines in serum, urine, Severity Score in CT scan, TNF-α in serum, urine and Clinical Severity Score.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 200 people.

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.