The Therapeutic Effects of Insulin and Berberine on Stress Hyperglycemia

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

Berberine is a conventional component in Chinese medicine.

The purpose of this study is to observe the therapeutic effects of combination of insulin and berberine on stress hyperglycemia in patients after cardiac surgery.

It had two arms (groups): Berberine; Insulin (experimental) and Insulin (active comparator).

Besides receiving intensive insulin therapy, participants will take a placebo twice a day for 8 days. Drug: Insulin.

The registry classes the interventions as drug.

More on the Plan

By lowering the glucose level, these patients have a lower incidence of arrhythmia, myocardial ischemia and reperfusion injury, and heart failure and so on.

The purpose of this study is to observe the therapeutic effects of combination of insulin and berberine on stress hyperglycemia in patients with heart disease whose level of blood glucose are not well controlled when only using insulin postoperatively.

This study will enroll postoperative patients who currently are injected with insulin by insulin pump，but the level of blood glucose is not controlled well.

Investigators will occur at preoperative baseline, operating time and postoperative days 2, 4 and 8.

Who Took Part

Enrollment: 200 planned participants were the target.

It was open to people of any sex.

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

Examples of who could join: Worsening glycemic control;. Individuals who had cardiac surgery before recruitment;.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: individuals with a history of diabetes;; individuals who are not able to cooperate;; female of childbearing potential;.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2016-07 with completion listed for 2017-03.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Evidence of effects of insulin and berberine on stress hyperglycemia (time frame: Within the first 10 days (plus or minus 3 days) after cardiac surgery).

It also tracked 2 secondary outcomes, for example Synergy of insulin and berberine on stress hyperglycemia and Mechanism of berberine on stress hyperglycemia.

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.