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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: Completed NA study, sponsored by University of California, San Francisco.

NCT00187564 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00187564 record still lists

NCT00187564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

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

NCT00187564 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00187564's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00187564, the US trial registry maintained by the National Library of Medicine. NCT00187564 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.