View Clinical Trial (Medical Research Study)
Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes
| City: |
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Kansas City |
| State: |
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Kansas |
| Zip Code: |
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66160 |
| Conditions: |
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Type 2 Diabetes - Oxidative Stress |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT00845130 |
| Primary Contact: |
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Principal Investigator
In-Young Choi, PhD
Un iversity of Kansas Medical Center
In-Young Choi, PhD
Phone: 913-588-0174
Email: ichoi@kumc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Kansas City, Kansas 66160
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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