Influence of Central Nervous Insulin Action on Insulin Sensitivity of Peripheral Organs in Lean Versus Overweight Humans

What Was Tested

This registered not phased trial tested Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

Research in animals and first experiments in humans indicate that insulin action in the brain regulates peripheral insulin sensitivity.

One major organ might be the liver.

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

Nasal spray containing placebo solution.

The registry classes the interventions as drug.

Who Took Part

The registry lists 21 actual participants took part.

It was open to men only aged from 18 years up to 40 years.

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

Examples of who could join: Male volunteers (lean or overweight/obese). Age between 18 and 40 years. Healthy as assessed by physician. Understanding the explanations about the study and instructions.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: non-removable metal parts in or on the body; cardiovascular disease can not be excluded, such as evident coronary heart disease, congestive heart failure nyha greater than 2, history of coronary artery disease; history of stroke.

How the Study Was Run

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

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

In the crossover set-up each of the insulin resistance, prediabetes & type 2 diabetes participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

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 2015-01 with completion listed for 2015-12.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Change in glucose infusion rate during hyperinsulinemic euglycemic glucose clamp from before to after nasal spray application in lean persons (time frame: Change from 70-90 min (before spray) to 170-210 min and to 280-300 min). Change in endogenous glucose production from before to after nasal spray application in lean persons (time frame: Change from 70-90 min (before spray) to 170-210 min and to 280-300 min). Differences in insulin response between lean and overweight persons (time frame: up to 210 minutes post nasal spray administration).

It also tracked 2 secondary outcomes, for example Autonomous nervous system activity and Regional brain insulin sensitivity.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 21 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.