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Clinical Trials/NCT00845130
NCT00845130
Completed
Not Applicable

Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

In-Young Choi, Ph.D.1 site in 1 country42 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
In-Young Choi, Ph.D.
Enrollment
42
Locations
1
Primary Endpoint
Concentration of Vitamin C in Type 2 Diabetic Patients.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Oxidative stress has been implicated in the development and complications of diabetes. Hyperglycemia and insulin resistance or insufficiency in diabetes can cause oxidative stress by excessive reactive oxygen species and can increase damage and alter antioxidant status in nerve cells. Antioxidant defense mechanisms protect against damage or restore oxidative damage. Glutathione, a powerful antioxidant plays a key role in the first line of antioxidant defense and seems to be a sensitive indicator of oxidative stress in various diseases such as diabetes. Glutathione functions in the regeneration of vitamin C which is another crucial antioxidant. Both hyperglycemia and insulin insufficiency inhibit uptake of vitamin C. The brain contains measurable amounts of glutathione that contribute to the antioxidant pool in the brain and guards against disease processes that are caused by oxidative stress. Since the brain is the most highly oxidative organ in the body and highly susceptible to oxidative stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C will be studied.

Detailed Description

The brain contains measurable amounts of glutathione that contribute to the antioxidant pool in the brain and guards against disease processes that are caused by oxidative stress. Since the brain is the most highly oxidative organ in the body and highly susceptible to oxidative stress, with increasing impact on diabetes, biomarkers of oxidative stress in the brain through the use of novel magnetic resonance imaging techniques for glutathione and vitamin C will be studied.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2014
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
In-Young Choi, Ph.D.
Responsible Party
Sponsor Investigator
Principal Investigator

In-Young Choi, Ph.D.

Associate Professor

University of Kansas Medical Center

Eligibility Criteria

Inclusion Criteria

  • 30-55 years of age
  • Diabetic being treated with diet and any of the following: insulin, or other diabetic specific drug such as metformin, sulfonylurea or sitagliptin.
  • Healthy subjects age and gender matched to diabetes patient

Exclusion Criteria

  • Use of any anti-inflammatory or antioxidant medications other than small daily doses of Aspirin (ASA:325 mg) and a daily multivitamin
  • Co-existing chronic inflammatory conditions such as Crohn's disease, rheumatoid arthritis, chronic or acute infections
  • Any concurrent neurological disease except for mild diabetic autonomic or peripheral neuropathy
  • Postmeal C peptide \> 0.3 mg/dl
  • Normal healthy subjects who have any abnormal inflammatory marker, hyperlipidemia, or concurrent disease
  • Diseases associated with abnormal glutathione metabolism
  • Elevated serum creatinine levels, abnormal complete blood count (CBC), abnormal liver function tests or elevated serum homocysteine
  • Morbid obesity
  • History of hypoglycemic unawareness
  • Pregnant women and women who are breastfeeding

Outcomes

Primary Outcomes

Concentration of Vitamin C in Type 2 Diabetic Patients.

Time Frame: Pre-Vitamin C infusion

Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.

Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier

Time Frame: 2 hour post infusion

Concentrations of vitamin C after IV infusion of Vitamin C were measured in the brains of patients with type 2 diabetes and healthy controls to examine whether the concentrations are different between two groups.

Study Sites (1)

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