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Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

This study is currently recruiting participants.
Verified January 2013 by University of Kansas
Sponsor:
Information provided by (Responsible Party):
In-Young Choi, Ph.D., University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00845130
First received: February 15, 2009
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  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: Parallel Assignment
Masking: Open Label
Official Title: Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Vitamin C levels [ Time Frame: Pre infusion, post infustion, after post infusion MRI ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ascorbic acid
 Biological: ascorbic acid (Vitamin C)
ascorbic acid IV 1 g/kg
Other Name: Vitamin C

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
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 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845130

Contacts
Contact: In-Young Choi, PhD 913-588-0174 ichoi@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
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

No publications provided

Responsible Party: In-Young Choi, Ph.D., Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00845130     History of Changes
Other Study ID Numbers: 11119
Study First Received: February 15, 2009
Last Updated: January 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Kansas:
Diabetes
MR imaging
Vitamin C

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Ascorbic Acid
Vitamins
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013