Insulin Sensitivity of the Human CNS System: fMRI Study With Intranasal Insulin Application

What Was Tested

In this not phased trial, researchers set out to test Insulin (regular human).

The purpose of the study is to investigate whether insulin sensitivity and insulin resistance of the human brain is comparable in all insulin sensitive parts of the brain and whether correlates to other phenotypic information (i.e. whole body insulin sensitivity, BMI, age) of the study participants.

It had two arms (groups): Human Insulin (active comparator) and Placebo solution (placebo comparator).

Nasal spray.

Nasal spray.

The registry classes the interventions as drug.

Who Took Part

48 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: Normal routine blood works. For women: negative pregnancy test.

The full record lists 3 inclusion and 14 exclusion criteria; among the exclusions: type 2 diabetes; acute or chronic diseases; artificial heart valves.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

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.

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2013-02 with completion listed for 2014-04.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Insulin effect on regional brain activity assessed by fMRI (time frame: Change from Baseline to 15 minutes and 60 minutes post spray application).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 48 people.

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, all human trials.