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

May 2, 2008 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143-0434
        • UCSF Division of Pediatric Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
1. Hb A1c
2. Urine albumin/creatinine ratio

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Stephen E Gitelman, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

May 6, 2008

Last Update Submitted That Met QC Criteria

May 2, 2008

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H7023-25421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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