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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187564
First received: September 13, 2005
Last updated: May 2, 2008
Last verified: September 2005
History of Changes
  Purpose

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
Diabetes Mellitus, Type 1
 Drug: controlled-release oral alpha-lipoic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Pilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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:
  • 1. Hb A1c
  • 2. Urine albumin/creatinine ratio

Estimated Enrollment: 40
Study Start Date: August 2004
Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187564

Locations
United States, California
UCSF Division of Pediatric Endocrinology
San Francisco, California, United States, 94143-0434
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Stephen E Gitelman, MD University of California, San Francisco
  More Information

Additional Information:
UCSF Diabetes Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Stephen E. Gitelman, UCSF
ClinicalTrials.gov Identifier: NCT00187564     History of Changes
Other Study ID Numbers: H7023-25421
Study First Received: September 13, 2005
Last Updated: May 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
Diabetes Mellitus, Type 1
lipoic acid
oxidative stress

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Thioctic Acid
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013