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Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A

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Nemours Children's Health

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Regular Insulin
Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia

Study type

Interventional

Funder types

Other

Identifiers

NCT00858897
JDRF 1-2006-627-A

Details and patient eligibility

About

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.

Full description

Adolescents with uncomplicated T1D will receive two, 5-hour infusions of deuterium-labeled cysteine on 2 separate days, a few weeks apart, while blood glucose will be maintained, using intravenous insulin infusion:

in the hyper-glycemic range (200-250 mg/dL) on one study day, and near normoglycemia (80-140 mg/dL) on the other study day.

The order of the study days will be randomized.

We will determine whether the level of blood glucose at the time of study affects blood glutathione concentration, and, if so, whether this is associated with changes in the fractional rate of glutathione synthesis, as determined from the incorporation of labeled cysteine into blood glutathione over the course of the 5-hr infusion of labeled cysteine.

Enrollment

10 patients

Sex

All

Ages

14 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 1 diabetes, using usual criteria such as: glycosuria, hyperglycemia prior to treatment
  • BMI <25 kg/m2
  • Age 14-18
  • HbA1c>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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Normoglycemia
Experimental group
Description:
80-140 mg/dL
Treatment:
Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia
Drug: Regular Insulin
Hyperglycemia
Experimental group
Description:
200-250 mg/dL
Treatment:
Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia
Drug: Regular Insulin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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