Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00775541

Enrollment

Registered

2008-10-20

Start date

2007-10-31

Completion date

2009-08-31

Last updated

2012-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Diabetes, Type 2 Diabetes

Brief summary

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.

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.

Interventions

DIETARY_SUPPLEMENTVitamin C

One IV infusion of 2 gm vitamin C

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
MRI, mRS, urine and blood samples	before and after IV infusion, 6 hours

Secondary

Measure	Time frame
7 day food and DHQ food questionnaire	7 days prior to MRI and vitamin C infusion

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026