Status:

COMPLETED

Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes

Lead Sponsor:

In-Young Choi, Ph.D.

Conditions:

Type 2 Diabetes

Oxidative Stress

Eligibility:

All Genders

30-55 years

Phase:

NA

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 reactiv...

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 t...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2014

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT00845130

Start Date

September 1 2009

End Date

December 1 2014

Last Update

May 3 2018

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160