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Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845130
First Posted: February 18, 2009
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
In-Young Choi, Ph.D., University of Kansas Medical Center
  Purpose
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.

Condition Intervention
Type 2 Diabetes Oxidative Stress Biological: ascorbic acid (Vitamin C)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

Resource links provided by NLM:


Further study details as provided by In-Young Choi, Ph.D., University of Kansas Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 42
Study Start Date: September 2009
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diabetic Type II Subjects
Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm
Biological: ascorbic acid (Vitamin C)
ascorbic acid IV 1 g/kg
Other Name: Vitamin C
Experimental: Healthy Subjects
Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm
Biological: ascorbic acid (Vitamin C)
ascorbic acid IV 1 g/kg
Other Name: Vitamin C

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.
  Eligibility

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845130


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 Un iversity of Kansas Medical Center
  More Information

Responsible Party: In-Young Choi, Ph.D., Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00845130     History of Changes
Other Study ID Numbers: 11119
First Submitted: February 15, 2009
First Posted: February 18, 2009
Results First Submitted: June 9, 2016
Results First Posted: July 21, 2016
Last Update Posted: March 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No, there is not a plan to share individual data.

Keywords provided by In-Young Choi, Ph.D., University of Kansas Medical Center:
Diabetes
MR imaging
Vitamin C

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents