Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00858273 |
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Recruitment Status :
Completed
First Posted : March 9, 2009
Results First Posted : May 17, 2023
Last Update Posted : May 17, 2023
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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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 41 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Antioxidant Supplement
Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg
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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 |
- Glutathione Concentration [ Time Frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%) ]While at near normoglycemia
- 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
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| Ages Eligible for Study: | 12 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| United States, Florida | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Principal Investigator: | Dominique Darmaun, MD, PhD | Nemours Children's Clinic |
| Responsible Party: | Nemours Children's Clinic |
| ClinicalTrials.gov Identifier: | NCT00858273 |
| Other Study ID Numbers: |
JDRF 1-2006-627-B |
| First Posted: | March 9, 2009 Key Record Dates |
| Results First Posted: | May 17, 2023 |
| Last Update Posted: | May 17, 2023 |
| Last Verified: | May 2012 |
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Glutathione |
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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 |