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Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes

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ClinicalTrials.gov Identifier: NCT00775541
Recruitment Status : Terminated (Insufficient dose for MRI scanning)
First Posted : October 20, 2008
Last Update Posted : June 18, 2012
Sponsor:
Information provided by (Responsible Party):
In-Young Choi, Ph.D., University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: Vitamin C Not Applicable

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  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes
Study Start Date : October 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vitamin C
2 gms vitamin C
Dietary Supplement: Vitamin C
One IV infusion of 2 gm vitamin C



Primary Outcome Measures :
  1. MRI, mRS, urine and blood samples [ Time Frame: before and after IV infusion, 6 hours ]

Secondary Outcome Measures :
  1. 7 day food and DHQ food questionnaire [ Time Frame: 7 days prior to MRI and vitamin C infusion ]


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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775541


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
In-Young Choi, Ph.D.
Investigators
Principal Investigator: In-Young Choi, PhD University of Kansas Medical Center

Responsible Party: In-Young Choi, Ph.D., Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00775541     History of Changes
Other Study ID Numbers: 11066
GCRC CReff 0082
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012

Keywords provided by In-Young Choi, Ph.D., University of Kansas Medical Center:
Diabetes
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents