Stress and the Nervous System

What Was Tested

In this not phased trial, researchers set out to test Cosyntropin.

This project will test the hypothesis that these delayed changes in autonomic nervous system function are secondary to a rise in ACTH.

The investigators will infuse cosyntropin versus placebo in a double-blind, crossover study in healthy adults and measure the delayed effects on the autonomic system as measured by cardiovagal baroreflex sensitivity.

It had two arms (groups): Cosyntropin (active comparator) and Normal saline (Placebo) (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Stress has complex effects on the body's physiology.

Models of stress such as hypoglycemia have identified that stress activates the hypothalamic-pituitary-adrenal (HPA) axis and sympathoadrenal system acutely.

Additionally, there are delayed effects of prior exposure to hypoglycemia.

This project will test the hypothesis that these delayed changes in autonomic nervous system function are secondary to a rise in ACTH that occurs in response to stress.

Who Took Part

23 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Complete blood count. Serum creatinine, sodium, potassium, glucose, liver enzymes. Urine pregnancy test (if female).

The full record lists 5 inclusion and 16 exclusion criteria; among the exclusions: systolic blood pressure \> 140 or \< 90 mm hg; diastolic blood pressure \> 90 mm hg; known dm, chf, cad, pvd, cva, mi, asthma.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Cosyntropin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Cosyntropin and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Cosyntropin, so expectations could not easily colour the readings.

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

It started in 2015-04 with completion listed for 2016-10.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Cardiovagal Baroreflex Sensitivity (Modified Oxford Technique) (time frame: Baseline, 4-hours after infusion, 24-hours after infusion).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cosyntropin in 23 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cosyntropin compound page, all human trials.