Diabetes Mellitus, Type 1NCT00858273
Glutathione Metabolism in Adolescents With Type 1 Diabetes - Study B
A study testing Antioxidant supplement, Diabetes treatment 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 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. Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Antioxidant supplement, Diabetes treatment and Regular Insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2011
- 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 12 to 21 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 12-21
- 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 B
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.
Read the detailed description
Forty adolescents with T1D will undergo a measurement of blood glutathione concentration and markers of oxidative stress (plasma protein-bound 3-nitrotyrosine, and urinary 8OH-2-dG, and F2-isoprostane excretion, markers of oxidative damage to protein, DNA and lipids, respectively) while at near normoglycemia, on two separate occasions:
- first, when in poor glucose control (HbA1c>7.5%); and
- secondly, after 3 to 9 months months of improved blood glucose control, along with the administration of either a placebo, or a mixture of antioxidant minerals and vitamins based on a randomization scheme.
Between the two metabolic study days, patients will receive the same intensified diabetes regimen consisting of education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Antioxidant supplement, Diabetes treatment, 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.
Antioxidant supplementDietary supplement
1 capsule daily with dinner
Diabetes treatmentOther
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 InsulinDrug
Regular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study
| Study group | Role | What they receive |
|---|---|---|
| Antioxidant Supplement | Active comparator | Vitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg Receives: Dietary Supplement: Antioxidant supplement; Other: Diabetes treatment; Drug: Regular Insulin |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Antioxidant supplement; Other: Diabetes treatment; Drug: Regular Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glutathione Concentration
While at near normoglycemia
Measured: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
Secondary outcomes (1)
Plasma Protein Bound 3-nitrotyrosine
Marker of oxidative stress
Measured: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2011
- Study completionAug 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Dominique Darmaun, MD, PhD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858273
- Sponsor's protocol ID
- JDRF 1-2006-627-B
- Status last verified
- May 2012
- First submitted
- 6 Mar 2009
- Last updated
- 17 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Benson 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.
PubMed 37515943
Study at a glance
From the registry record, last updated by the sponsor on 17 May 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 B
- ClinicalTrials.gov ID
- NCT00858273
- Acronym / sponsor ID
- JDRF 1-2006-627-B
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Glutathione
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 17 May 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 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.
Detailed description
Forty adolescents with T1D will undergo a measurement of blood glutathione concentration and markers of oxidative stress (plasma protein-bound 3-nitrotyrosine, and urinary 8OH-2-dG, and F2-isoprostane excretion, markers of oxidative damage to protein, DNA and lipids, respectively) while at near normoglycemia, on two separate occasions:
- first, when in poor glucose control (HbA1c>7.5%); and
- secondly, after 3 to 9 months months of improved blood glucose control, along with the administration of either a placebo, or a mixture of antioxidant minerals and vitamins based on a randomization scheme.
Between the two metabolic study days, patients will receive the same intensified diabetes regimen consisting of education and counseling, home blood glucose monitoring, multiple daily insulin injections (MDI), diet plan, and frequent phone contact with a certified diabetes educator.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antioxidant Supplement | Active comparator | Dietary Supplement: Antioxidant supplement, Other: Diabetes treatment, Drug: Regular InsulinVitamin C 250 mg; beta-carotene 6 mg; vitamin E 30 mg; selenium 100 mcg; zinc 20 mg |
| Placebo | Placebo comparator | Dietary Supplement: Antioxidant supplement, Other: Diabetes treatment, Drug: Regular Insulin |
Who may qualify
- Ages
- 12 to 21 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 12-21
- 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 |
|---|---|---|
| Antioxidant supplement1 capsule daily with dinner | Dietary supplement | Antioxidant Supplement, Placebo |
| Diabetes treatmentIntensification 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 | Other | Antioxidant Supplement, Placebo |
| Regular InsulinRegular Insulin, IV, to maintain blood glucose in normoglycemic range (70-140) during metabolic study | Drug | Antioxidant Supplement, Placebo |
Primary outcome
Glutathione Concentration
Time frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
While at near normoglycemia
1 secondary outcome
Plasma Protein Bound 3-nitrotyrosine
Time frame: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37515943Benson 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.
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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 Antioxidant supplement, Diabetes treatment 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 17 May 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. Some participants in this study may receive a placebo. 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 17 May 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: After 3-9 months of improved blood glucose control (HbA1c decrease of >0.5%)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858273, which also lists 1 linked publication.
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 17 May 2023.