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Completed

NCT Number: NCT00187564

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

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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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Division of Pediatric Endocrinology

San Francisco, California, 94143-0434, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • fasting plasma glucose >= 126 mg/dL, or
  • 2 hour postprandial glucose >= 200 mg/dL
  • 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

  • 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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Treatment and study plan

controlled-release oral alpha-lipoic acid

Drug

Primary outcomes

  1. 1. protein carbonyl (measurement of oxidized protein)

  2. 2. Thiobarbituric Acid Reactive Substances (TBARS) (measurement of oxidized lipid)

  3. 3. 8-Oxo-dG/8-Oxo-dA (measurement of oxidized DNA)

  4. 4. Trolox equivalent antioxidant capacity (TEAC) (measurement of total antioxidant status)

Secondary outcomes

  1. 1. Hb A1c

  2. 2. Urine albumin/creatinine ratio

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Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2004
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
May 6, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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