CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Regular Insulin +1 moredrug
Likely dose
Regular Insulin 140 mgfrom 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/NCT00858897
NCT00858897N/ACompleted

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

Nemours Children's Clinic·interventional·Posted Mar 10, 2009·Updated Jul 10, 2023

In Brief

A clinical study evaluating Cysteine isotope infusion at normoglycemia vs hyperglycemia and Regular Insulin for Diabetes Mellitus, Type 1. Completed, enrolled 10 participants across 1 site.

Detailed Summary

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. Since glutathione is continuously synthesized and broken down, the amount of glutathione present in blood depends on the balance between its rate of synthesis and its rate of use. In earlier studies, the investigators found that in poorly controlled diabetic teenagers, glutathione was low, not because its production was decreased, but because it was used at an excessive rate. In this study, the investigators want to determine how short-term changes in blood sugar levels affect glutathione levels. This will help improve our understanding of how diabetes affects metabolism.

Study Details

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

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2009
Enrollment StartJun 1, 2007
Primary CompletionFeb 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.3 years ago

Interventions

Cysteine isotope infusion at normoglycemia vs hyperglycemiaother

L-\[3,3-2H2\]cysteine

Regular Insulindrug

Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) or hyperglycemic range (200-250 mg/mL) during metabolic studies