Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B

Completed · Not applicable · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT00858273

Run by

Nemours Children's Clinic

People needed

41

Starts

2008-03-01

Expected to finish

2011-08-01

Last updated by the study team

2023-05-17

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes, using usual criteria such as: glycosuria, hyperglycemia prior to treatment
• BMI <25 kg/m2
• Age 12-21
• HbA1c>7.5%
• No evidence of diabetic complications
• Written informed consent from parents or legal guardian, and assent from patient

You may not qualify if…

• Presence of significant anemia (hemoglobin <11g/dL)
• 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
• Use of vitamin or mineral supplements within 2 weeks of study

Where it is running

• Nemours Children's Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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