The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
breakfast size
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring breakfast size, blood glucose balance, hormonal profile, appetite hormones, adipokines, pro-inflammatory cytokines
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
Sites / Locations
- Diabetes Unit, Wolfson Medical Center
- Diabetes Unit, Wolfson Medical Center
Outcomes
Primary Outcome Measures
blood glucose balance
HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark
Secondary Outcome Measures
anthropometric parameters
weight, height, body composition
Adipokines and hormones
insulin, leptin, ghrelin, adiponectin, GLP-1, cortisol
pro-inflammatory cytokines
TNF-α, IL-6, MCP-1, CRP
lipid profile
triglycerides, cholesterol, LDL, HDL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01178723
Brief Title
The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wolfson Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
breakfast size, blood glucose balance, hormonal profile, appetite hormones, adipokines, pro-inflammatory cytokines
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
breakfast size
Intervention Description
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
Primary Outcome Measure Information:
Title
blood glucose balance
Description
HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark
Time Frame
three months
Secondary Outcome Measure Information:
Title
anthropometric parameters
Description
weight, height, body composition
Time Frame
three months
Title
Adipokines and hormones
Description
insulin, leptin, ghrelin, adiponectin, GLP-1, cortisol
Time Frame
three months
Title
pro-inflammatory cytokines
Description
TNF-α, IL-6, MCP-1, CRP
Time Frame
three months
Title
lipid profile
Description
triglycerides, cholesterol, LDL, HDL
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julio Wainstein, M.D
Phone
03-5028716
Email
vainstein@wolfson.health.gov.il
Facility Information:
Facility Name
Diabetes Unit, Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Diabetes Unit, Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Wainstein, M.D
Phone
03-5028716
Email
Vainstein@wolfson.health.gov.il
12. IPD Sharing Statement
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The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
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