Completed

Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study A

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What is being tested

Cysteine isotope infusion at normoglycemia vs hyperglycemia

+ Regular Insulin

OtherDrug
Who is being recruted

Autoimmune Diseases+5

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 1

From 14 to 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: June 2007
See protocol details

Summary

Principal SponsorNemours Children's Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2007

Actual date on which the first participant was enrolled.

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.

Official TitleRegulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study A
NCT00858897
Principal SponsorNemours Children's Clinic
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 14 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDiabetes MellitusDiabetes Mellitus, Type 1Endocrine System DiseasesImmune System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 inclusion criteria required to participate
Type 1 diabetes, using usual criteria such as: glycosuria, hyperglycemia prior to treatment
BMI <25 kg/m2
Age 14-18
HbA1c>7.5%
Show More Criteria
5 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
200-250 mg/dL

Group II

Experimental
80-140 mg/dL

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Nemours Children's Clinic

Jacksonville, United StatesOpen Nemours Children's Clinic in Google Maps
CompletedOne Study Center