Antioxidant Use in Diabetes to Reduce Oxidative Stress

Specific Aim 1. Recruit non pregnant women with T1DM and investigate the efficacy of dietary
NAC on ameliorating oxidative stress Study design. Diabetic patients will be provided with
NAC or placebo for 14 days, while receiving usual clinical care. The oxidative stress status
will be assessed by measuring biomarkers in blood samples pre and post intervention. In
addition to a placebo control group, three treatment groups including Group 1 (NAC 600
mg/day), Group 2 (NAC 1200 mg/day), and Group 3 (NAC 1800 mg/day) will be studied. The choice
of dosage of NAC is based on published studies, which show effectiveness of NAC in 600 or
1200 mg day in alleviating oxidative stress in diabetic patients, both in men and women,
without adverse side effects. The investigators will use the supplement company TwinLab for
our study. The university of Maryland Pharmacy department will analyze the NAC for purity
prior to starting the study. At day 7, participants will be called via phone assess for
symptoms and side effects from medications. All participants will be called. At the end of 14
days, the patients will return to the CDE with a survey asking about compliance with
medication and any side effects. They will also bring the pill bottle so that study personnel
can do a pill count. At this time blood will be draw for the biomarker levels to look for
changes in oxidative stress.

Specific Aim 2. To investigate effect of PUFAs on ameliorating oxidative stress in diabetic
non-pregnant women.

Study design: The investigators will recruit a new group of Non-pregnant women with T1DM will
be enrolled and randomly assigned to placebo or one of three treatment groups. Study
volunteers will be divided into 1 of 3 groups. PUFA; Group 1 (1000 mg/day) or Group 2 (2000
mg/day) or Group 3(placebo). The treatment regimens, sample collection, biomarker assessment,
side effect monitoring and statistical analysis will be performed as described in SA 1. The
investigators will perform an analysis of the oxidative stress biomarkers as described in
SA1. The investigators will use TwinLab as our commercial supplier of PUFA for our trial.
There fish oil supplements have been involved in greater than 40 published trials. The fish
oil supplement will be analyzed by the University of Maryland pharmacy department prior to
starting the study to analyze for purity.

Specific Aim 3: To investigate the potential secondary benefit of NAC/PUFA on kidney function
and lipid profile. Urine and serum samples will be collected on all enrolled subjects at day
0 and Day 14 to monitor for improvement in microalbumin in the urine and lipid profile in the
serum. Previous studies have shown improvements in LDL with supplementation of NAC. The
investigators will look at how various dosages effect the improvement in microalbumin and
lipid profile.

Inclusion Criteria:

- hemoglobin a1c <10

- type 1 diabetes

Exclusion Criteria:

- pregnancy

- BMI > 40

- greater than 1 alcoholic beverages per week

- any tobacco use

- prescribed nitroglycerin, HIV protease inhibits, corticosteroids, cephalosporins, or
blood thinners

- vascular complications(history of coronary artery disease, cerebral vascular accident,
transient ischemic attack, claudication).