Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A

What Was Tested

This registered not phased trial tested Insulin (regular human).

Glutathione is normally present at high (millimolar) levels in blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by reactive oxygen species produced by the metabolism of most nutrients, including glucose.

Glutathione is a small peptide made from 3 amino acids, glutamate, cysteine, and glycine.

This study is looking at how blood sugar levels may affect the way glutathione is made and used by the body.

It had two arms (groups): Normoglycemia (experimental) and Hyperglycemia (experimental).

The registry classes the interventions as drug and other.

More on the Plan

The order of the study days will be randomized.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 14 years up to 18 years.

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

Examples of who could join: BMI \<25 kg/m2. No evidence of diabetic complications. Written informed consent from parents or legal guardian, and assent from patient.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: presence of intercurrent illness such as infection; presence of chronic disease such as other endocrine deficiency, chronic respiratory or cardiac disease; chronic use of medication other than insulin.

How the Study Was Run

Design: randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2007-06 with completion listed for 2008-02.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Glutathione Concentration.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 10 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 Insulin (regular human) compound page, all human trials.