Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Dietary Supplement: Vitamin C |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes |
- MRI, mRS, urine and blood samples [ Time Frame: before and after IV infusion, 6 hours ] [ Designated as safety issue: Yes ]
- 7 day food and DHQ food questionnaire [ Time Frame: 7 days prior to MRI and vitamin C infusion ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | October 2007 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitamin C
2 gms vitamin C
|
Dietary Supplement: Vitamin C
One IV infusion of 2 gm vitamin C
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Presence of mental illness
- Co-existing chronic inflammatory condition or neurological disease or diseases associated with abnormal glutathione metabolism
- BMI over 35
- Smoker
Contacts and Locations| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: | In-Young Choi, PhD | University of Kansas |
More Information
No publications provided
| Responsible Party: | In-Young Choi, Ph.D., Assistant Professor, University of Kansas Medical Center Research Institute |
| ClinicalTrials.gov Identifier: | NCT00775541 History of Changes |
| Other Study ID Numbers: | 11066, GCRC CReff 0082 |
| Study First Received: | October 17, 2008 |
| Last Updated: | June 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Kansas:
|
Diabetes Type 2 Diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Ascorbic Acid Vitamins |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013