Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187564
Status:
COMPLETED
Last Update Posted:
2008-05-06
First Post:
2005-09-13
Brief Title:
Pilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Pilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None