Type 2 DiabetesNCT00775541
Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes
A study testing Vitamin C in people with Type 2 Diabetes, run by In-Young Choi, Ph.D. at 1 site in United States.
Trial summary
The purpose of this study is to use an MRI exam to measure the concentrations of glutathione (GSH) and Vitamin C (Asc) in the brains of normal healthy persons and type 2 diabetic persons. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Good health except for having type 2 diabetes
- Being treated with diet, insulin, or oral hyperglycemic agents
- Male or non pregnant female
- Non-smoker
- HbA1c 8 or above
- Able to provide informed consent
Who cannot join
- Presence of mental illness
- Co-existing chronic inflammatory condition or neurological disease or diseases associated with abnormal glutathione metabolism
- BMI over 35
- Smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The purpose of this study is to use an MRI exam to measure the concentrations of glutathione (GSH) and Vitamin C (Asc) in the brains of normal healthy persons and type 2 diabetic persons. The study will look at the relationship between chronic hyperglycemia and the levels of these naturally occurring chemicals in the brain.
Read the detailed description
Cerebral GSH and Asc concentrations are modulated by increased oxidative stress induced by hyperglycemia in diabetes and reflect changes in the cerebral antioxidant defense system. Inhibition of cellular uptake of Asc by hyperglycemia further hampers maintaining adequate antioxidant capacities. Reduced concentrations of these antioxidants might serve as good indicators of increased susceptibility to oxidative damage, impaired cellular uptake or the antioxidant, and further, as sensitive in vivo biomarkers to assess early manifestations or progression of diabetic complications and the efficacy of the antioxidant therapy in the human brain. Specific aims (1) to determine cerebral concentrations of GSH and Asc in the living brain of healthy controls and type 2 diabetic patients; (2) to quantify the effect of chronic hyperglycemia on cellular uptake of Asc across the blood-brain barrier.
- Conditions
- Type 2 Diabetes
- Being tested
- Vitamin C
- Keywords
- Diabetes, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
One IV infusion of 2 gm vitamin C
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | 2 gms vitamin C Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI, mRS, urine and blood samples
Measured: before and after IV infusion, 6 hours
Secondary outcomes (1)
7 day food and DHQ food questionnaire
Measured: 7 days prior to MRI and vitamin C infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startOct 2007
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Insufficient dose for MRI scanning
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- In-Young Choi, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, In-Young Choi, Ph.D., University of Kansas Medical Center
- Investigators
- In-Young Choi, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775541
- Sponsor's protocol ID
- 11066
- Other IDs
- GCRC CReff 0082
- Status last verified
- Jun 2012
- First submitted
- 17 Oct 2008
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes
- ClinicalTrials.gov ID
- NCT00775541
- Acronym / sponsor ID
- 11066
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient dose for MRI scanning
- Enrolment
- 5 participants (actual)
- Lead sponsor
- In-Young Choi, Ph.D.University, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use an MRI exam to measure the concentrations of glutathione (GSH) and Vitamin C (Asc) in the brains of normal healthy persons and type 2 diabetic persons. The study will look at the relationship between chronic hyperglycemia and the levels of these naturally occurring chemicals in the brain.
Detailed description
Cerebral GSH and Asc concentrations are modulated by increased oxidative stress induced by hyperglycemia in diabetes and reflect changes in the cerebral antioxidant defense system. Inhibition of cellular uptake of Asc by hyperglycemia further hampers maintaining adequate antioxidant capacities. Reduced concentrations of these antioxidants might serve as good indicators of increased susceptibility to oxidative damage, impaired cellular uptake or the antioxidant, and further, as sensitive in vivo biomarkers to assess early manifestations or progression of diabetic complications and the efficacy of the antioxidant therapy in the human brain. Specific aims (1) to determine cerebral concentrations of GSH and Asc in the living brain of healthy controls and type 2 diabetic patients; (2) to quantify the effect of chronic hyperglycemia on cellular uptake of Asc across the blood-brain barrier.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Dietary Supplement: Vitamin C2 gms vitamin C |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Good health except for having type 2 diabetes
- Being treated with diet, insulin, or oral hyperglycemic agents
- Male or non pregnant female
- Non-smoker
- HbA1c 8 or above
Key exclusion criteria (4 listed)
- Presence of mental illness
- Co-existing chronic inflammatory condition or neurological disease or diseases associated with abnormal glutathione metabolism
- BMI over 35
- Smoker
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 |
|---|---|---|
| Vitamin COne IV infusion of 2 gm vitamin C | Dietary supplement | Vitamin C |
Primary outcome
MRI, mRS, urine and blood samples
Time frame: before and after IV infusion, 6 hours
1 secondary outcome
7 day food and DHQ food questionnaire
Time frame: 7 days prior to MRI and vitamin C infusion
Results and safety
The study was stopped early (reason given: Insufficient dose for MRI scanning). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
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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.
In-Young Choi, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Type 2 Diabetes, run by In-Young Choi, Ph.D. 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 4 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: stopped early, as of the sponsor's last update on 18 Jun 2012. 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?
The study was stopped early (reason given: Insufficient dose for MRI scanning). Results are not available in the source record.
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?
MRI, mRS, urine and blood samples (time frame: before and after IV infusion, 6 hours). 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 18 Jun 2012.