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

NCT00187564 | Completed

• 1 other identifier: H7023-25421
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1; lipoic acid; oxidative stress

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 1. Hb A1c

• 2. Urine albumin/creatinine ratio

Interventions

controlled-release oral alpha-lipoic acid DRUG

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Division of Pediatric Endocrinology

San Francisco, California, 94143-0434, United States

Location

Related Links

• UCSF Diabetes Center

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Stephen E Gitelman, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2004
• Study Completion: October 1, 2005
• Last Updated: May 6, 2008

Record last verified: 2005-09

Locations

US (1)