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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187564
• Other study ID #: H7023-25421
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: May 2, 2008
• Start date: August 2004
• Est. completion date: October 2005

Study information

• Verified date: September 2005
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 21 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• controlled-release oral alpha-lipoic acid

Locations

Country	Name	City	State
United States	UCSF Division of Pediatric Endocrinology	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. protein carbonyl (measurement of oxidized protein)
Primary	2. Thiobarbituric Acid Reactive Substances (TBARS) (measurement of oxidized lipid)
Primary	3. 8-Oxo-dG/8-Oxo-dA (measurement of oxidized DNA)
Primary	4. Trolox equivalent antioxidant capacity (TEAC) (measurement of total antioxidant status)
Secondary	1. Hb A1c
Secondary	2. Urine albumin/creatinine ratio

External Links

•   UCSF Diabetes Center