Diabetes Mellitus Clinical Trial
Official title:
Egg Effects on Atherogenic Dyslipidemia, Glucose Metabolism and Inflammation in Diabetic Subjects
There is concern in the literature regarding egg consumption in diabetic people. The
investigators hypothesis is that compared to an oatmeal-based breakfast, an egg-based
breakfast will not increase the risk for heart disease in diabetic people but it may reduce
inflammation, in this population characterized by chronic low grade inflammation.
This is a cross-over study in which subjects will be randomly allocated to consume 1 egg per
day for breakfast or a bowl of oatmeal with lactose-free milk for 5 weeks. After a 3 wk
washout period, subjects will be allocated to the alternate treatment for additional 5
weeks.
Blood will be collected at baseline and at the end of each dietary period to measure plasma
lipids, glucose, insulin, glycosylated hemoglobin and inflammatory markers.
This study is conducted in diabetic patients who are given two distinct breakfasts: eggs and
oatmeal in a crossover design. The investigators hypothesis is that eggs will not increase
the risk for heart disease in this population when compared to oatmeal but they will more
likely reduce inflammation due to the presence of the carotenoids, lutein and zeaxanthin
that are highly available in eggs.
In this study, the investigators are evaluating three main things
- Atherogenic dyslipidemia by measuring plasma lipids and lipoprotein mean size and
subfractions by nuclear magnetic resonance.
- Glucose metabolism by measuring plasma glucose, insulin, insulin resistance and
glycosylated hemoglobin.
- Inflammation by measuring liver enzymes, C reactive protein, tumor necrosis
factor-alpha, interleukin-6.
All these measurements were done 24 weeks after completion of the study All data will be
presented 1 year after completion of the study
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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