- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00858897
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A
Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study A
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescents with uncomplicated T1D will receive two, 5-hour infusions of deuterium-labeled cysteine on 2 separate days, a few weeks apart, while blood glucose will be maintained, using intravenous insulin infusion:
- in the hyper-glycemic range (200-250 mg/dL) on one study day, and
- near normoglycemia (80-140 mg/dL) on the other study day.
The order of the study days will be randomized.
We will determine whether the level of blood glucose at the time of study affects blood glutathione concentration, and, if so, whether this is associated with changes in the fractional rate of glutathione synthesis, as determined from the incorporation of labeled cysteine into blood glutathione over the course of the 5-hr infusion of labeled cysteine.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Normoglycemia
80-140 mg/dL
|
L-[3,3-2H2]cysteine
Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) or hyperglycemic range (200-250 mg/mL) during metabolic studies
|
Experimental: Hyperglycemia
200-250 mg/dL
|
L-[3,3-2H2]cysteine
Regular insulin, IV, as needed to maintain blood glucose in near-normoglycemic range (80-140 mg/dL) or hyperglycemic range (200-250 mg/mL) during metabolic studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
umol/L
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dominique Darmaun, MD, PhD, Nemours Children's Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JDRF 1-2006-627-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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