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Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B

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ClinicalTrials.gov Identifier: NCT00858273
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : May 4, 2012
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Nemours Children's Clinic

Brief 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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Dietary Supplement: Antioxidant supplement Other: Diabetes treatment Drug: Regular Insulin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study B
Study Start Date : March 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

Arm Intervention/treatment
Active Comparator: Antioxidant Supplement
Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg
Dietary Supplement: Antioxidant supplement
1 capsule daily with dinner

Other: Diabetes treatment
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

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

Placebo Comparator: Placebo Dietary Supplement: Antioxidant supplement
1 capsule daily with dinner

Other: Diabetes treatment
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

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




Primary Outcome Measures :
  1. Restoration of glutathione homeostasis, measured by glutathione concentration while at near normoglycemia [ Time Frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%) ]

Secondary Outcome Measures :
  1. Decrease in markers of oxidative stress (plasma protein bound 3-nitrotyrosine, urinary 8OH-2'-deoxyguanosine, urinary F2-isoprostane) [ Time Frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858273


Locations
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United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Juvenile Diabetes Research Foundation
Investigators
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Principal Investigator: Dominique Darmaun, MD, PhD Nemours Children's Clinic

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Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00858273     History of Changes
Other Study ID Numbers: JDRF 1-2006-627-B
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012

Keywords provided by Nemours Children's Clinic:
Glutathione

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Antioxidants
Hypoglycemic Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents