N/A
N=10
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT00858897 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Glutathione Concentration — 541; 551 umol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cysteine isotope infusion at normoglycemia vs hyperglycemia (Other); Regular Insulin (Drug)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glutathione Concentration |
541; 551 | — |
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.
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 (NCT00858897). 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.