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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00187564 |
The long-term effects of high blood sugar include blindness, kidney failure, and nerve damage that can ultimately cause loss of limbs. Research has shown that high blood sugar increases the amount of reactive oxygen species (ROS) produced in diabetics, and that the increase in ROS causes damage to eyes, kidneys, and nerves by a process called "oxidative stress." We postulate that alpha-lipoic acid, a potent anti-oxidant, can stop ROS from forming, thereby preventing long-term complications in diabetes. In this pilot study, we will be giving 30 teenagers with type 1 diabetes (T1D) controlled-release alpha-lipoic acid for 3 months, and comparing the amount of oxidative stress before and after treatment. Ten teenagers with T1D will receive placebo instead of alpha-lipoic acid and undergo the same research protocol to aid in validation of outcome measures.
Condition | Intervention |
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Diabetes Mellitus, Type 1 |
Drug: controlled-release oral alpha-lipoic acid |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Pilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus |
Estimated Enrollment: | 40 |
Study Start Date: | August 2004 |
Study Completion Date: | October 2005 |
Ages Eligible for Study: | 8 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have diabetes by 1997 ADA criteria:
Exclusion Criteria:
1. Subjects must not have history of eye, kidney or nerve damage 2. Subjects must not be deemed unable or unlikely to comply with the protocol. Children who are unable to swallow pills, or are unwilling to take pills twice daily will be excluded from the study.
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United States, California | |
UCSF Division of Pediatric Endocrinology | |
San Francisco, California, United States, 94143-0434 |
Principal Investigator: | Stephen E Gitelman, MD | University of California, San Francisco |
Responsible Party: | UCSF ( Stephen E. Gitelman ) |
Study ID Numbers: | H7023-25421 |
Study First Received: | September 13, 2005 |
Last Updated: | May 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00187564 |
Health Authority: | United States: Food and Drug Administration |
Diabetes Mellitus, Type 1 lipoic acid oxidative stress |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Stress Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Thioctic Acid |
Antioxidants Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immune System Diseases Growth Substances |
Vitamins Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |