Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00775541
• Other study ID #: 11066
• Secondary ID: GCRC CReff 0082
• Status: Terminated
• Phase: N/A
• First received: October 17, 2008
• Last updated: June 15, 2012
• Start date: October 2007
• Est. completion date: August 2009

Study information

• Verified date: June 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hyperglycemia
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Vitamin C
One IV infusion of 2 gm vitamin C

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
In-Young Choi, Ph.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI, mRS, urine and blood samples		before and after IV infusion, 6 hours	Yes
Secondary	7 day food and DHQ food questionnaire		7 days prior to MRI and vitamin C infusion	No