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NCT Number: NCT00858897

Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cysteine isotope infusion at normoglycemia vs hyperglycemia

Other

L-[3,3-2H2]cysteine

Regular insulin

Drug

Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) or hyperglycemic range (200-250 mg/mL) during metabolic studies

Primary outcomes

  1. Glutathione Concentration

    Time frame: Up to 30 minutes post- 5 hour infusion on Day 1 (First Intervention) and up to 30 minutes post- 5 hour infusion on Day 14 (Second Intervention)

    umol/L

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study A

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Mar 10, 2009
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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