Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845130
• Other study ID #: 11119
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: December 2014

Study information

• Verified date: April 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

• Patients with poor venous access

• Smokers

• Subject who consumes an excess of alcohol or abuses drugs

• History or or presence of bleeding disorder or use of anticoagulant drug

• History of oxalate renal calculi

Related Conditions & MeSH terms

• Diabetes Mellitus
• Oxidative Stress
• Type 2 Diabetes

Intervention

Biological:
• ascorbic acid (Vitamin C)
ascorbic acid IV 1 g/kg

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	Concentration of Vitamin C in Type 2 Diabetic Patients.	Concentrations of vitamin C were measured in the brains of type 2 Diabetic patients and healthy controls.	Pre-Vitamin C infusion
Primary	Quantify the Effect of Chronic Hyperglycemia on Cellular Uptake of Vitamin C Across the Blood-brain Barrier	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.	2 hour post infusion