Diabetes Mellitus, Type 1NCT00858897
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study A
A study testing Cysteine isotope infusion at normoglycemia vs hyperglycemia and Regular Insulin in people with Diabetes Mellitus, Type 1, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Cysteine isotope infusion at normoglycemia vs hyperglycemia and Regular Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Cysteine isotope infusion at normoglycemia vs hyperglycemia, Regular Insulin
- Keywords
- Glutathione
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cysteine isotope infusion at normoglycemia vs hyperglycemiaOther
L-[3,3-2H2]cysteine
Regular InsulinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Normoglycemia | Experimental | 80-140 mg/dL Receives: Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia; Drug: Regular Insulin |
| Hyperglycemia | Experimental | 200-250 mg/dL Receives: Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia; Drug: Regular Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutathione Concentration
umol/L
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startJun 2007
- Primary completionFeb 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Principal investigator, Dominique Darmaun, Nemours Children's Clinic
- Investigators
- Dominique Darmaun, MD, PhD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858897
- Sponsor's protocol ID
- JDRF 1-2006-627-A
- Status last verified
- Jun 2023
- First submitted
- 6 Mar 2009
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Glutathione Homeostasis in Adolescents With Type 1 Diabetes - Study A
- ClinicalTrials.gov ID
- NCT00858897
- Acronym / sponsor ID
- JDRF 1-2006-627-A
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Glutathione
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Jun 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Posted 10 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normoglycemia | Experimental | Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia, Drug: Regular Insulin80-140 mg/dL |
| Hyperglycemia | Experimental | Other: Cysteine isotope infusion at normoglycemia vs hyperglycemia, Drug: Regular Insulin200-250 mg/dL |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cysteine isotope infusion at normoglycemia vs hyperglycemiaL-[3,3-2H2]cysteine | Other | Hyperglycemia, Normoglycemia |
| Regular InsulinRegular 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 | Drug | Hyperglycemia, Normoglycemia |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Darmaun, MD, PhD principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cysteine isotope infusion at normoglycemia vs hyperglycemia and Regular Insulin in people with Diabetes Mellitus, Type 1, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.