Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B

What Was Tested

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

Glutathione is normally present at high levels in the blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by several 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): Antioxidant Supplement (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as dietary supplement, drug and other.

Who Took Part

The registry lists 41 actual participants took part.

It was open to people of any sex aged from 12 years up to 21 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, parallel-group and triple-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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2008-03 with completion listed for 2011-03.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Glutathione Concentration.

It also tracked 1 secondary outcome, for example Plasma Protein Bound 3-nitrotyrosine.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 41 people.

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.