The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Type 2 |
Dietary Supplement: breakfast size |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
- blood glucose balance [ Time Frame: three months ] [ Designated as safety issue: No ]HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark
- anthropometric parameters [ Time Frame: three months ] [ Designated as safety issue: No ]weight, height, body composition
- Adipokines and hormones [ Time Frame: three months ] [ Designated as safety issue: No ]insulin, leptin, ghrelin, adiponectin, GLP-1, cortisol
- pro-inflammatory cytokines [ Time Frame: three months ] [ Designated as safety issue: No ]TNF-α, IL-6, MCP-1, CRP
- lipid profile [ Time Frame: three months ] [ Designated as safety issue: No ]triglycerides, cholesterol, LDL, HDL
| Estimated Enrollment: | 48 |
-
Dietary Supplement: 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
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| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Julio Wainstein, M.D | 03-5028716 | vainstein@wolfson.health.gov.il |
| Israel | |
| Diabetes Unit, Wolfson Medical Center | Not yet recruiting |
| Holon, Israel, 58100 | |
| Diabetes Unit, Wolfson Medical Center | Not yet recruiting |
| Holon, Israel, 58100 | |
| Contact: Julio Wainstein, M.D 03-5028716 Vainstein@wolfson.health.gov.il | |
More Information
No publications provided
| Responsible Party: | Dr Julio Wainstein, Diabetes Unit, Wolfson Medical Center |
| ClinicalTrials.gov Identifier: | NCT01178723 History of Changes |
| Other Study ID Numbers: | TASMC10JW0080CTIL |
| Study First Received: | August 8, 2010 |
| Last Updated: | August 8, 2010 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Wolfson Medical Center:
|
breakfast size blood glucose balance hormonal profile |
appetite hormones adipokines pro-inflammatory cytokines |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013