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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| controlled-release oral alpha-lipoic acid | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 1. protein carbonyl (measurement of oxidized protein) | ||
| 2. Thiobarbituric Acid Reactive Substances (TBARS) (measurement of oxidized lipid) | ||
| 3. 8-Oxo-dG/8-Oxo-dA (measurement of oxidized DNA) | ||
| 4. Trolox equivalent antioxidant capacity (TEAC) (measurement of total antioxidant status) |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Hb A1c | ||
| 2. Urine albumin/creatinine ratio |
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Inclusion Criteria:
Subjects must be pubertal (defined as Tanner stage II or greater), or post-pubertal, with an upper age limit of 21 years.
Subjects must have diabetes by 1997 ADA criteria:
Subjects must have history of least one auto-antibody associated with T1D, either glutamic acid decarboxylase (GADA) or islet cell autoantigen 512 (ICA512), or history of diabetic ketoacidosis.
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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| Name | Affiliation | Role |
|---|---|---|
| Stephen E Gitelman, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Division of Pediatric Endocrinology | San Francisco | California | 94143-0434 | United States |
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| Label | URL |
|---|---|
| UCSF Diabetes Center | View source |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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