This study is evaluating the impact of antioxidant supplements on blood sugar control and cardiovascular risk factors in adults over the age of 50 with at 3 months of Type 2 diabetes. The investigators hypothesize that daily supplementation with a multiple micronutrient formulation containing dietary and endogenous antioxidants in combination with usual care will reduce markers of oxidative stress and inflammation in Type 2 diabetes.
This study is evaluating the impact of an antioxidant and micronutrient supplement on markers of oxidative stress and inflammation as well as on blood sugar control in adults over the age of 50 who have had Type 2 diabetes for at least 3 months. The purpose of this study is to see if these antioxidants reduce the oxidative and inflammatory state seen in patients with Type 2 diabetes as well as whether or not they make it easier to control blood sugar, affect the number and dosage of diabetic medications, and/or reduce the risk factors involved in long-term diabetes related complications such as in lipid profile and carotid intima-media thickness (CIMT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
111
This group will be randomized to take the anti-oxidant and micronutrient supplement.
This group will take a placebo.
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Change in the markers of oxidative stress and inflammation
Determining a difference between the control and experimental groups in the following markers of 1) oxidative stress: 9-Malondialdehyde (MDA) in plasma, 3-Nitrotyrosine in plasma, and Urinary levels of F2-isoprostane and 8 hydroxy,deoxyguanosine; and 2) inflammation: GM-CSF, IFN-γ, IL-1β, IL-2, L-4, IL-5, IL-6, IL-10, IL-12 (p40/p70), TNF-α.
Time frame: baseline, 6, and 12 months
Change in CIMT
Determine if a difference exists in CIMT measurements between the control and experimental groups.
Time frame: Baseline, 6 and 12 months
Change in medications
Compare the experimental and control groups to determine if medication use has changed over the course of the study.
Time frame: Baseline, 3, 6, 9, and 12 months
Change in lipid profile
Compare the control and experimental groups to determine differences in lipid profile over time.
Time frame: baseline, 3, 6, 9, and 12 months
Hemoglobin A1c
Determine the difference in quarterly A1c measurements between the experimental and control groups over the course of the study.
Time frame: baseline, 3, 6, 9, and 12 months
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