Pupillography as Screening Tool for Brain Insulin Resistance

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

Cerebral insulin action is important in the regulation of whole body glucose metabolism.

However, the cerebral insulin action differs between individuals - there is a so called cerebral insulin resistance.

The influence of central insulin action on peripheral metabolism seems at least partially mediated via the autonomous nervous system.

It had two arms (groups): nasal insulin (active comparator) and nasal placebo (placebo comparator).

Placebo as nasal spray.

The registry classes the interventions as diagnostic test and drug.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age between 18 and 60 years.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: there is a pregnancy or pregnancy can not be excluded; lactating women; minors or non-consenting subjects are also excluded.

How the Study Was Run

The set-up was randomized, crossover and single-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.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2018-07-03 with completion listed for 2018-11-01.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Measurements of autonomic nervous system activity by pupillography (time frame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application). Measurements of latency of pupil response to light stimulation (time frame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application). Measurements of amplitude of pupil response to light stimulation (time frame: Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application).

It also tracked 1 secondary outcome, for example Autonomic nervous system.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 22 people with insulin resistance, prediabetes & type 2 diabetes.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.