An interventional study of Antioxidant supplement and Diabetes treatment in Diabetes Mellitus, Type 1, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Open to participants aged 12 Years to 21 Years. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Basic science
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.
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:
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 41 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Nemours Children's Clinic is the lead sponsor of 127 studies on the registry; 27 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg
Dietary Supplement: Antioxidant supplement · Other: Diabetes treatment · Drug: Regular Insulin
Dietary Supplement: Antioxidant supplement · Other: Diabetes treatment · Drug: Regular Insulin
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
Glutathione Concentration
While at near normoglycemia
Time frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
Plasma Protein Bound 3-nitrotyrosine
Marker of oxidative stress
Time frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
| Milestone | Antioxidant Supplement | Placebo |
|---|---|---|
| Started | 20 | 20 |
| Completed | 17 | 15 |
| Not completed | 3 | 5 |
| Withdrew: Protocol violation | 3 | 5 |
While at near normoglycemia
| umol/L | Antioxidant Supplement | Placebo |
|---|---|---|
| Glutathione Concentration | 706 ± 236 | 734 ± 215 |
Marker of oxidative stress
| ng/mL | Antioxidant Supplement | Placebo |
|---|---|---|
| Plasma Protein Bound 3-nitrotyrosine | 4.26 (1.65 to 19) | 7.13 (1.22 to 10.9) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antioxidant Supplement | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Placebo | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
8 of the 40 Participants were not eligible for the second admission to the CRC due to the inability to drop their HbA1C by 0.5% within the time frame of the project. Therefore, 32 Participants were used for analysis.
| Age, Categorical(Participants) | Antioxidant Supplement | Placebo | Total |
|---|---|---|---|
| <=18 years | 17 | 15 | 32 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Antioxidant Supplement | Placebo | Total |
|---|---|---|---|
| Mean | 15.7 ± 2.3 | 15.8 ± 2.6 | 15.8 ± 2.4 |
| Sex: Female, Male(Participants) | Antioxidant Supplement | Placebo | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 14 | 12 | 26 |
| Region of Enrollment(participants) | Antioxidant Supplement | Placebo | Total |
|---|---|---|---|
| United States | 17 | 15 | 32 |
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Nemours Children's Clinic