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NCT00187564 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT00187564 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants.

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The verdict

NCT00187564, a NA study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study 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.

Interventions

  • DRUG controlled-release oral alpha-lipoic acid

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2004-08
Est. Completion 2005-10
Phase NA

What the Registry Record Tells You About NCT00187564

The ClinicalTrials.gov registry entry for NCT00187564 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which controlled-release oral alpha-lipoic acid is the first listed.

NCT00187564 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00187564 about?

NCT00187564 is a clinical study titled "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 e...

What is the current status of trial NCT00187564?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2004-08. Estimated completion is 2005-10.

What interventions are being tested in trial NCT00187564?

The interventions under investigation include: controlled-release oral alpha-lipoic acid (DRUG).

Who is sponsoring clinical trial NCT00187564?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.