Diabetes Mellitus, Type 2 Clinical Trial
Studies has found a connection between breakfast consumption and obesity and obesity-related
complications, but only few studies examined the effect of breakfast size.
The purpose of this study is to examine the effect of breakfast size on several parameters
in adults with Type 2 diabetes mellitus.
The prevalence of obesity has rapidly increased during recent decades, while the prevalence
of skipping breakfast has increased.
Several studies have reported inverse relationships between the consumption of breakfast and
BMI and weight gain. A study that examined the effect of breakfast size, found that an
increased percentage of daily energy consumed at breakfast was associated with relatively
lower weight gain. Preliminary results of clinical research (unpublished) show a connection
between a large breakfast and weight loss and increased feeling of satiety throughout the
day.
The purpose of this study is to examine the effect of breakfast size on blood glucose
balance, and its correlation with hormonal profile (including appetite hormones), adipokines
and pro-inflammatory cytokines, weight and body composition and lipid profile in adults with
type 2 diabetes.
The study will use a randomized-controlled, non-blinded, prospective design, including 48
participants with type 2 diabetes, who are not insulin dependent.
The research group will receive instructions to eat a large breakfast compared with the
control group that will receive instructions to eat a small breakfast.
The estimated duration of the study is about three months.
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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