The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
NCT ID: NCT01178723
Last Updated: 2010-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
48 participants
INTERVENTIONAL
Brief Summary
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The purpose of this study is to examine the effect of breakfast size on several parameters in adults with Type 2 diabetes mellitus.
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Detailed Description
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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 Preliminary results of clinical research (unpublished) show a connection between a large breakfast and weight loss and increased feeling of satiety throughout the day.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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Interventions
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breakfast size
The research group will receive instructions to eat a large breakfast, Dividing the total daily calories recommended to the patient to: breakfast - 1/8 of the total daily calories , lunch - 1/3 of the total daily calories and supper- 1/3 of the total daily calories.
(the rest of the calories will be snacks between the meals) In contrast, the control group that will receive instructions to eat a small breakfast.
Dividing the total daily calories recommended to the patient to: breakfast - 1/3 of the total daily calories , lunch - 1/4 of the total daily calories and supper- 1/4 of the total daily calories (the rest of the calories will snacks between the meals).
The instructions will be adapted to each patient individually
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
70 Years
ALL
No
Sponsors
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Wolfson Medical Center
OTHER_GOV
Responsible Party
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Wolfson Medical Center
Locations
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Diabetes Unit, Wolfson Medical Center
Holon, , Israel
Diabetes Unit, Wolfson Medical Center
Holon, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TASMC10JW0080CTIL
Identifier Type: -
Identifier Source: org_study_id
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