Pilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT00187564
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Study Completion: 2005-10
• Last Update Submitted: 2008-05-02
• Last Update Posted: 2008-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Subjects must be pubertal (defined as Tanner stage II or greater), or post-pubertal, with an upper age limit of 21 years.

2. Subjects must have diabetes by 1997 ADA criteria:

   1. fasting plasma glucose >= 126 mg/dL, or
   2. 2 hour postprandial glucose >= 200 mg/dL

3. 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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
1. Hb A1c
2. Urine albumin/creatinine ratio

Trial Locations

Locations (1)

UCSF Division of Pediatric Endocrinology; 🇺🇸 San Francisco, California, United States