Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DIETARY_SUPPLEMENT

Antioxidant supplement

1 capsule daily with dinner

OTHER

Diabetes treatment

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

DRUG

Regular Insulin

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

Sponsors & Collaborators

• Juvenile Diabetes Research Foundation

  collaborator OTHER

• Nemours Children's Clinic

  lead OTHER

Principal Investigators

• Dominique Darmaun, MD, PhD · Nemours Children's Clinic

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2011-03-31

Completion

2011-08-31

Countries

• United States

Study Locations