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Completed

NCT Number: NCT00858273

Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B

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.

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Key information

Age range

12 year–21 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

Forty adolescents with T1D will undergo a measurement of blood glutathione concentration and markers of oxidative stress (plasma protein-bound 3-nitrotyrosine, and urinary 8OH-2-dG, and F2-isoprostane excretion, markers of oxidative damage to protein, DNA and lipids, respectively) while at near normoglycemia, on two separate occasions:

  • first, when in poor glucose control (HbA1c>7.5%); and
  • secondly, after 3 to 9 months months of improved blood glucose control, along with the administration of either a placebo, or a mixture of antioxidant minerals and vitamins based on a randomization scheme.

Between the two metabolic study days, patients will receive the same intensified diabetes regimen consisting of education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator.

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 12-21
  • 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

Antioxidant supplement

Dietary Supplement

1 capsule daily with dinner

Diabetes Treatment

Other

Intensification of diabetes treatment regimen, including education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator

Regular insulin

Drug

Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study

Primary outcomes

  1. Glutathione Concentration

    Time frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)

    While at near normoglycemia

Secondary outcomes

  1. Plasma Protein Bound 3-nitrotyrosine

    Time frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)

    Marker of oxidative stress

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 B

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2009
Registry last updated
May 17, 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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