An interventional study of ascorbic acid (Vitamin C) in Type 2 Diabetes and Oxidative Stress, sponsored by In-Young Choi, Ph.D.. Completed at 1 site in United States. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-03.
Sponsored by In-Young Choi, Ph.D. · Not applicable, Interventional, and Other
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 42 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →In-Young Choi, Ph.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm
Biological: ascorbic acid (Vitamin C)
Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm
Biological: ascorbic acid (Vitamin C)
ascorbic acid IV 1 g/kg
Also known as: Vitamin C
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.
Time frame: 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.
Time frame: 2 hour post infusion
| Milestone | Diabetic Type II Subjects | Healthy Subjects |
|---|---|---|
| Started | 20 | 22 |
| Completed | 16 | 19 |
| Not completed | 4 | 3 |
Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.
| umol/g tissue | Diabetic Type II Subjects | Healthy Subjects |
|---|---|---|
| Concentration of Vitamin C in Type 2 Diabetic Patients. | 1.1 ± 0.2 | 1.2 ± 0.1 |
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.
| µmol/g tissue | Diabetic Type II Subjects | Healthy Subjects |
|---|---|---|
| Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier | 1.1 ± 0.2 | 1.4 ± 0.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diabetic Type II Subjects | — | 0/16 (0%) | 0/16 (0%) |
| Healthy Subjects | — | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Diabetic Type II Subjects | Health Subjects | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 19 | 35 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Diabetic Type II Subjects | Health Subjects | Total |
|---|---|---|---|
| Mean | 48 ± 5 | 45 ± 7 | 47 ± 6 |
| Sex: Female, Male(Participants) | Diabetic Type II Subjects | Health Subjects | Total |
|---|---|---|---|
| Female | 7 | 12 | 19 |
| Male | 9 | 7 | 16 |
| Region of Enrollment(participants) | Diabetic Type II Subjects | Health Subjects | Total |
|---|---|---|---|
| United States | 16 | 19 | 35 |
Plan to share: No — No, there is not a plan to share individual data.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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In-Young Choi, Ph.D.