Trial · Interventional

CompletedNot applicableResults postedRegistry data

Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B

NCTNCT00858273Other idJDRF 1-2006-627-B

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Glutathione, does not give it. It appears in an outcome measure.

Overview

Status: Completed
Phase: Not applicable
Enrollment: 41 participants (actual)
Sponsor: Nemours Children's Clinic · Other
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Mar 2008
Primary completion: Mar 2011
Completion: Aug 2011
First posted: 9 Mar 2009 (estimated)
Last update posted: 17 May 2023
Conditions: Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20082009201020112012

N/A
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B
NCT00858273
Mar 2008 to Aug 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Antioxidant supplementDietary supplement
Diabetes treatmentOther
Regular InsulinDrug

Arms2

Active comparator
Antioxidant Supplement
Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg
Placebo comparator
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

Glutathione Concentration
Time frame · After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
Registry description
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%)
Registry description
Marker of oxidative stress

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)

Glutathione Concentration

Group	Value (umol/L)	Spread
Antioxidant Supplement	706	236
Placebo	734	215

Secondary and other outcome results(1)

Secondary outcomeMedian· After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)

Plasma Protein Bound 3-nitrotyrosine

Group	Value (ng/mL)
Antioxidant Supplement	4.26
Placebo	7.13

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Antioxidant SupplementVitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg Antioxidant supplement: 1 capsule daily with dinner 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 Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study	0 / 17	0 / 17	0 / 17
PlaceboAntioxidant supplement: 1 capsule daily with dinner 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 Regular Insulin: Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study	0 / 15	0 / 15	0 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedBenson M, Hossain J, Darmaun D. Improved glycemic control either alone, or combined with antioxidant supplementation, fails to restore blood glutathione or markers of oxidative stress in adolescents with poorly controlled type 1 diabetes. Nutr Res. 2023 Sep;117:83-90. doi: 10.1016/j.nutres.2023.05.010. Epub 2023 May 25. PMID 37515943

Eligibility

Who could join, as posted.

Sex: All
Age: from 12 Years up to 21 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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