Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A

NCTNCT00858897Other idJDRF 1-2006-627-A

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: 10 participants (actual)
Sponsor: Nemours Children's Clinic · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jun 2007
Primary completion: Feb 2008
Completion: Feb 2009
First posted: 10 Mar 2009 (estimated)
Last update posted: 10 Jul 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

2007200820092010

N/A
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A
NCT00858897
Jun 2007 to Feb 2009

Registry summary

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

Glutathione is normally present at high (millimolar) levels in blood and plays an important role in the body's defense against oxidative stress, that is, against the damage caused to the body by 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 blood depends on the balance between its rate of synthesis and its rate of use. In earlier studies, the investigators found that in poorly controlled diabetic teenagers, glutathione was low, not because its production was decreased, but because it was used at an excessive rate. In this study, the investigators want to determine how short-term changes in blood sugar levels affect glutathione levels. This will help improve our understanding of how diabetes affects metabolism.

Interventions

Cysteine isotope infusion at normoglycemia vs hyperglycemiaOther
Regular InsulinDrug

Arms2

Experimental
Normoglycemia
80-140 mg/dL
Experimental
Hyperglycemia
200-250 mg/dL

Primary outcomes1

Outcomes the sponsor listed as primary.

Glutathione Concentration
Time frame · Up to 30 minutes post- 5 hour infusion on Day 1 (First Intervention) and up to 30 minutes post- 5 hour infusion on Day 14 (Second Intervention)
Registry description
umol/L

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· Up to 30 minutes post- 5 hour infusion on Day 1 (First Intervention) and up to 30 minutes post- 5 hour infusion on Day 14 (Second Intervention)

Glutathione Concentration

Group	Value (umol/L)	Spread
Normoglycemia (80-140 mg/dL)	541	232
Hyperglycemia (200-250 mg/dL)	551	169

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Normoglycemia (80-140 mg/dL)Cysteine isotope infusion at normoglycemia vs hyperglycemia: L-\[3,3-2H2\]cysteine Regular Insulin: Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) during metabolic studies. Each of the 10 Subjects received two 5-hour intravenous infusions on 2 separate days after blood glucose had been maintained overnight at normoglycemia or hyperglycemia, using intravenous insulin infusion.	0 / 10	0 / 10	0 / 10
Hyperglycemia (200-250 mg/dL)Cysteine isotope infusion at normoglycemia vs hyperglycemia: L-\[3,3-2H2\]cysteine Regular Insulin: Regular insulin, IV, as needed to maintain blood glucose in hyperglycemic range (200-250 mg/mL) during metabolic studies. Each of the 10 Subjects received two 5-hour intravenous infusions on 2 separate days after blood glucose had been maintained overnight at normoglycemia or hyperglycemia, using intravenous insulin infusion.	0 / 10	0 / 10	0 / 10

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.

Eligibility

Who could join, as posted.

Sex: All
Age: from 14 Years up to 18 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 14-18 * 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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