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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic Type II Subjects | Experimental | Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm |
|
| Healthy Subjects | Experimental | Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ascorbic acid (Vitamin C) | Biological | ascorbic acid IV 1 g/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 2 hour post infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Young Choi, PhD | Un iversity of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
No, there is not a plan to share individual data.
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All subjects were consented to participate in the study. After baseline information was gathered from labs, it was determined that seven subjects did not meet the inclusion criteria. They were excluded from completing the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Diabetic Type II Subjects | Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm). |
| FG001 | Healthy Subjects | Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Diabetic Type II Subjects | Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm). |
| BG001 | Health Subjects | Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Determine cerebral concentrations of vitamin C. Data from one healthy subject were not usable due to subject's movement during MRI scan. | Posted | Mean | Standard Deviation | umol/g tissue | Pre-Vitamin C infusion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetic Type II Subjects | Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| In-Young Choi, Ph.D. | Univeristy of Kansas Medical Center | 913-588-0174 | ichoi@kumc.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Data from one healthy subject were not usable due to subject's movement during MRI scan. | Posted | Mean | Standard Deviation | µmol/g tissue | 2 hour post infusion |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Healthy Subjects | Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm). | 0 | 19 | 0 | 19 |
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| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |