Back to resultsPilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
controlled-release oral alpha-lipoic acid
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, lipoic acid, oxidative stress
Eligibility Criteria
Inclusion Criteria: 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 2 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. 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. -
Sites / Locations
- UCSF Division of Pediatric Endocrinology
Outcomes
Primary Outcome Measures
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
1. Hb A1c
2. Urine albumin/creatinine ratio
Full Information
NCT ID
NCT00187564
First Posted
September 13, 2005
Last Updated
May 2, 2008
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00187564
Brief Title
Pilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus
Official Title
Pilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, San Francisco
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes Mellitus, Type 1, lipoic acid, oxidative stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
controlled-release oral alpha-lipoic acid
Primary Outcome Measure Information:
Title
1. protein carbonyl (measurement of oxidized protein)
Title
2. Thiobarbituric Acid Reactive Substances (TBARS) (measurement of oxidized lipid)
Title
3. 8-Oxo-dG/8-Oxo-dA (measurement of oxidized DNA)
Title
4. Trolox equivalent antioxidant capacity (TEAC) (measurement of total antioxidant status)
Secondary Outcome Measure Information:
Title
1. Hb A1c
Title
2. Urine albumin/creatinine ratio
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
2 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.
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen E Gitelman, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Division of Pediatric Endocrinology
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0434
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.diabetes.ucsf.edu/
Description
UCSF Diabetes Center
Learn more about this trial
Pilot Study on the Effect of Oral Controlled-Release Alpha-Lipoic Acid on Oxidative Stress in Adolescents With Type 1 Diabetes Mellitus
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