Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human).

Applying intranasal insulin bypasses blood-brain barrier and cause elevation of insulin concentrations in the cerebrospinal fluid without major effects on peripheral insulin level.

It had three arms (groups): Intranasal 40 (experimental), Intranasal 80 (experimental) and Placebo (placebo comparator).

Patients will receive intranasal normal saline via a metered nasal dispenser.

The registry classes the interventions as drug.

More on the Plan

Presently it is not clear if CNS insulin plays a relevant role in controlling blood glucose in humans.

Patients undergoing major surgery are exposed to metabolic and endocrine alterations in carbohydrate, protein, and insulin metabolism, often summarized as the catabolic stress response.

Who Took Part

Enrollment: 141 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 0 inclusion and 3 exclusion criteria; among the exclusions: planned use of drugs that effect plasma glucose concentration during the first four hours of surgery; patients with allergy to insulin.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2016-09 with completion listed for 2021-09.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Blood Glucose (time frame: During Surgery). Plasma Insulin (time frame: During Surgery). Cerebrospinal Fluid Insulin (time frame: During Surgery).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 141 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.