Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Antioxidant supplement; Diabetes treatment; Regular Insulin
Intervention type(s): Dietary Supplement; Other; Drug
Intervention description(s): 1 capsule daily with dinner; 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, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Glutathione