Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes

This study has been terminated.
(Insufficient dose for MRI scanning)
Sponsor:
Information provided by (Responsible Party):
In-Young Choi, Ph.D., University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00775541
First received: October 17, 2008
Last updated: June 15, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • MRI, mRS, urine and blood samples [ Time Frame: before and after IV infusion, 6 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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, Type 2
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on September 29, 2014