Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

NCT00845130 | Completed Results DMC

• 1 other identifier: 11119
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Oxidative Stress

Keywords

Diabetes; MR imaging; Vitamin C

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Diabetic Type II Subjects

EXPERIMENTAL

Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm

Biological: ascorbic acid (Vitamin C)

Healthy Subjects

EXPERIMENTAL

Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm

Biological: ascorbic acid (Vitamin C)

Interventions

ascorbic acid (Vitamin C) BIOLOGICAL

ascorbic acid IV 1 g/kg

Also known as: Vitamin C

Diabetic Type II Subjects; Healthy Subjects

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• In-Young Choi, Ph.D.: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: In-Young Choi, Ph.D.
• Organization: Univeristy of Kansas Medical Center

ichoi@kumc.edu

913-588-0174

Study Officials

• In-Young Choi, PhD

  Un iversity of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2009
• First Posted: February 18, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 3, 2018
• Results First Posted: July 21, 2016

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)