Clinical trial NCT01178723: The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: breakfast size
blood glucose balance
hormonal profile
appetite hormones
adipokines
pro-inflammatory cytokines
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-10
Enrollment: 48
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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 Preliminary results of clinical research (unpublished) show a connection between a large breakfast and weight loss and increased feeling of satiety throughout the day.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.

Eligibility criteria: Inclusion Criteria:

* Men and women ages: 30-70
* Type 2 diabetics who are treated on a diet and / or pills
* Patients who receive a stable drug treatment (no change in the type/dosage of drugs during the three months preceding the research)
* Obese or overweight (35\> BMI\> 25)
* Patients who did not participate in another research for at least 30 days
* Patients who agree to sign a consent form and participate in research
* Patients with high compliance.

Exclusion Criteria:

* Patients under the age 30 or over 70
* Type 1 I diabetics
* Patients who are insulin dependent
* Type 2 diabetics who are treated with injections
* BMI less than 25 or BMI over 35
* Patients who had Bariatric surgery
* Patients with food absorption disorders
* Active malignant disease
* Thyroid function disorder
* Active psychiatric illness
* Pregnancy / breastfeeding

Primary outcomes:
measure: blood glucose balance
timeFrame: three months
Secondary outcomes:
measure: anthropometric parameters
timeFrame: three months
measure: Adipokines and hormones
timeFrame: three months
measure: pro-inflammatory cytokines
timeFrame: three months
measure: lipid profile
timeFrame: three months
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Diabetes Unit, Wolfson Medical Center
city: Holon
country: Israel
facility: Diabetes Unit, Wolfson Medical Center
Study officials:
References: