Type 2 DiabetesNCT00845130
Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes
A study testing ascorbic acid (Vitamin C) in people with Type 2 Diabetes and Oxidative Stress, run by In-Young Choi, Ph.D. at 1 site in United States.
Trial summary
Oxidative stress has been implicated in the development and complications of diabetes. Hyperglycemia and insulin resistance or insufficiency in diabetes can cause oxidative stress by excessive reactive oxygen species and can increase damage and alter antioxidant status in nerve cells. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Oxidative Stress
- What is being tested?
- ascorbic acid (Vitamin C)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2014
- 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 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 30-55 years of age
- Diabetic being treated with diet and any of the following: insulin, or other diabetic specific drug such as metformin, sulfonylurea or sitagliptin.
- Healthy subjects age and gender matched to diabetes patient
Who cannot join
- Use of any anti-inflammatory or antioxidant medications other than small daily doses of Aspirin (ASA:325 mg) and a daily multivitamin
- Co-existing chronic inflammatory conditions such as Crohn's disease, rheumatoid arthritis, chronic or acute infections
- Any concurrent neurological disease except for mild diabetic autonomic or peripheral neuropathy
- Postmeal C peptide > 0.3 mg/dl
- Normal healthy subjects who have any abnormal inflammatory marker, hyperlipidemia, or concurrent disease
- Diseases associated with abnormal glutathione metabolism
Show all 15Show fewer
- Elevated serum creatinine levels, abnormal complete blood count (CBC), abnormal liver function tests or elevated serum homocysteine
- Morbid obesity
- History of hypoglycemic unawareness
- Pregnant women and women who are breastfeeding
- Patients with poor venous access
- Smokers
- Subject who consumes an excess of alcohol or abuses drugs
- History or or presence of bleeding disorder or use of anticoagulant drug
- History of oxalate renal calculi
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Oxidative stress has been implicated in the development and complications of diabetes. Hyperglycemia and insulin resistance or insufficiency in diabetes can cause oxidative stress by excessive reactive oxygen species and can increase damage and alter antioxidant status in nerve cells. Antioxidant defense mechanisms protect against damage or restore oxidative damage. Glutathione, a powerful antioxidant plays a key role in the first line of antioxidant defense and seems to be a sensitive indicator of oxidative stress in various diseases such as diabetes. Glutathione functions in the regeneration of vitamin C which is another crucial antioxidant. Both hyperglycemia and insulin insufficiency inhibit uptake of vitamin C. The brain contains measurable amounts of glutathione that contribute to the antioxidant pool in the brain and guards against disease processes that are caused by oxidative stress. Since the brain is the most highly oxidative organ in the body and highly susceptible to oxidative stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C will be studied.
Read the detailed description
The brain contains measurable amounts of glutathione that contribute to the antioxidant pool in the brain and guards against disease processes that are caused by oxidative stress. Since the brain is the most highly oxidative organ in the body and highly susceptible to oxidative stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C will be studied.
- Conditions
- Type 2 Diabetes, Oxidative Stress
- Being tested
- ascorbic acid (Vitamin C)
- Keywords
- Diabetes, MR imaging, Vitamin C
- 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.
ascorbic acid (Vitamin C)Biological
Also called Vitamin C
ascorbic acid IV 1 g/kg
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Type II Subjects | Experimental | Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm Receives: Biological: ascorbic acid (Vitamin C) |
| Healthy Subjects | Experimental | Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm Receives: Biological: ascorbic acid (Vitamin C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Vitamin C in Type 2 Diabetic Patients.
Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.
Measured: Pre-Vitamin C infusion
Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier
Concentrations of vitamin C after IV infusion of Vitamin C were measured in the brains of patients with type 2 diabetes and healthy controls to examine whether the concentrations are different between two groups.
Measured: 2 hour post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2014
- Study completionDec 2014
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 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 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, Un iversity of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845130
- Sponsor's protocol ID
- 11119
- Status last verified
- Apr 2018
- First submitted
- 15 Feb 2009
- Last updated
- 3 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No, there is not a plan to share individual data.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes
- ClinicalTrials.gov ID
- NCT00845130
- Acronym / sponsor ID
- 11119
- Conditions
- Type 2 Diabetes, Oxidative Stress
- Keywords
- Diabetes, MR imaging, Vitamin C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- In-Young Choi, Ph.D.University, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Posted 21 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxidative stress has been implicated in the development and complications of diabetes. Hyperglycemia and insulin resistance or insufficiency in diabetes can cause oxidative stress by excessive reactive oxygen species and can increase damage and alter antioxidant status in nerve cells. Antioxidant defense mechanisms protect against damage or restore oxidative damage. Glutathione, a powerful antioxidant plays a key role in the first line of antioxidant defense and seems to be a sensitive indicator of oxidative stress in various diseases such as diabetes. Glutathione functions in the regeneration of vitamin C which is another crucial antioxidant. Both hyperglycemia and insulin insufficiency inhibit uptake of vitamin C. The brain contains measurable amounts of glutathione that contribute to the antioxidant pool in the brain and guards against disease processes that are caused by oxidative stress. Since the brain is the most highly oxidative organ in the body and highly susceptible to oxidative stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C will be studied.
Detailed description
The brain contains measurable amounts of glutathione that contribute to the antioxidant pool in the brain and guards against disease processes that are caused by oxidative stress. Since the brain is the most highly oxidative organ in the body and highly susceptible to oxidative stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C will be studied.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Type II Subjects | Experimental | Biological: ascorbic acid (Vitamin C)Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm |
| Healthy Subjects | Experimental | Biological: ascorbic acid (Vitamin C)Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 30-55 years of age
- Diabetic being treated with diet and any of the following: insulin, or other diabetic specific drug such as metformin, sulfonylurea or sitagliptin.
- Healthy subjects age and gender matched to diabetes patient
Key exclusion criteria (15 listed)
- Use of any anti-inflammatory or antioxidant medications other than small daily doses of Aspirin (ASA:325 mg) and a daily multivitamin
- Co-existing chronic inflammatory conditions such as Crohn's disease, rheumatoid arthritis, chronic or acute infections
- Any concurrent neurological disease except for mild diabetic autonomic or peripheral neuropathy
- Postmeal C peptide > 0.3 mg/dl
- Normal healthy subjects who have any abnormal inflammatory marker, hyperlipidemia, or concurrent disease
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 |
|---|---|---|
| ascorbic acid (Vitamin C)Also: Vitamin Cascorbic acid IV 1 g/kg | Biological | Diabetic Type II Subjects, Healthy Subjects |
Primary outcome
Concentration of Vitamin C in Type 2 Diabetic Patients.
Time frame: Pre-Vitamin C infusion
Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.
Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier
Time frame: 2 hour post infusion
Concentrations of vitamin C after IV infusion of Vitamin C were measured in the brains of patients with type 2 diabetes and healthy controls to examine whether the concentrations are different between two groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No, there is not a plan to share individual data.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
Un iversity 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 ascorbic acid (Vitamin C) in people with Type 2 Diabetes and Oxidative Stress, 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 3 inclusion and 15 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 3 May 2018. 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 21 Jul 2016). 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?
Concentration of Vitamin C in Type 2 Diabetic Patients. (time frame: Pre-Vitamin C infusion). The study lists 2 primary outcomes in all. 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 3 May 2018.