The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
1 other identifier
interventional
48
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2010
CompletedFirst Posted
Study publicly available on registry
August 10, 2010
CompletedAugust 10, 2010
August 1, 2010
August 8, 2010
August 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood glucose balance
HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark
three months
Secondary Outcomes (4)
anthropometric parameters
three months
Adipokines and hormones
three months
pro-inflammatory cytokines
three months
lipid profile
three months
Interventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Diabetes Unit, Wolfson Medical Center
Holon, 58100, Israel
Diabetes Unit, Wolfson Medical Center
Holon, 58100, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
August 8, 2010
First Posted
August 10, 2010
Last Updated
August 10, 2010
Record last verified: 2010-08