N/A
Completed N=40
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00858273 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Glutathione Concentration — 706; 734 umol/L
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glutathione Concentration |
706; 734 | — |
| SECONDARY Plasma Protein Bound 3-nitrotyrosine |
4.26; 7.13 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes, using usual criteria such as: glycosuria, hyperglycemia prior to treatment
- BMI 7.5%
- No evidence of diabetic complications
- Written informed consent from parents or legal guardian, and assent from patient
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00858273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.