Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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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

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Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Vitamin C

2 gms vitamin C

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

One IV infusion of 2 gm vitamin C

Interventions

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Vitamin C

One IV infusion of 2 gm vitamin C

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No