Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes

June 15, 2012 updated by: In-Young Choi, Ph.D.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin C
2 gms vitamin C
Dietary supplement: Vitamin C
One IV infusion of 2 gm vitamin C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MRI, mRS, urine and blood samples
Time Frame: before and after IV infusion, 6 hours
before and after IV infusion, 6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
7 day food and DHQ food questionnaire
Time Frame: 7 days prior to MRI and vitamin C infusion
7 days prior to MRI and vitamin C infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

In-Young Choi, Ph.D.

Investigators

  • Principal Investigator: In-Young Choi, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Estimate)

June 18, 2012

Last Update Submitted That Met QC Criteria

June 15, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11066
  • GCRC CReff 0082

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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