CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Regular Insulin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00858273
NCT00858273N/ACompleted

Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study B

Nemours Children's Clinic·interventional·Posted Mar 9, 2009·Updated May 17, 2023

In Brief

A clinical study evaluating Antioxidant supplement, Diabetes treatment, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 41 participants across 1 site.

Detailed Summary

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. Since glutathione is continuously synthesized and broken down, the amount of glutathione present in the blood depends on the balance between its rate of synthesis and its rate of use. In earlier studies, we found that in poorly controlled diabetic teenagers, glutathione was low, not because it was not produced fast enough, but because it was used at an excessive rate. In this study, we want to find out whether improving blood sugar control will increase glutathione levels, and, if so, how long this will take. We also hope to find out if oral supplementation with a mixture of several antioxidant vitamins and minerals will increase glutathione levels more than taking a placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 9, 2009
Enrollment StartMar 1, 2008
Primary CompletionMar 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17.3 years ago

Interventions

Antioxidant supplementdietary

1 capsule daily with dinner

Diabetes treatmentother

Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator

Regular Insulindrug

Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study