Type II Diabetes Mellitus Clinical Trial
Official title:
Effects of Krill Oil on Endothelial Function in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the effects of krill oil supplementation in
patients with Type 2 diabetes mellitus on heart health and laboratory diabetic measurements.
Patients who enroll in this study will be asked to visit the Western Connecticut Health
Network Biomedical Research Institute on 3 separate occasions: for baseline testing, after 4
weeks of supplementing with krill oil, and after 4 weeks of supplementing with a placebo.
Patients will be randomized into one of two groups to determine the order in which they
receive the supplement and placebo. Every patient will receive both the krill oil and the
placebo, but both the coordinator and the patient are blinded to which is which. At each
visit, participants will undergo a non-invasive test which measures the function of the
inner lining of blood vessels and they will also have blood drawn. Fasting is required
before each appointment. The blood drawn is used to measure their Hemoglobin A1C, Glucose,
HDL, LDL, total cholesterol, C-peptide and total antioxidant capacity.
Risks to taking krill oil supplements are likely to include bad breath, heartburn, fishy
taste, upset stomach, nausea, loose stools, gas, and bloating. Risks of EndoPAT testing are
not permanent and may include pain, numbness, tingling, redness, and bruising at the site of
the blood pressure cuff. Risks that are associated with drawing blood may include redness,
swelling, pain or discomfort, bruising at the site of the needle stick, or in very rare
cases, infection at the needle site. To minimize these risks, trained technologists and
phlebotomists will be used for all procedures.
This is not a treatment option; while involved in this study all participants will continue
their regular treatment for Type 2 diabetes mellitus (as well as any other applicable
conditions).
n/a
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