The Effects of Breakfast Size on Hormonal Profile in Adults With Type 2 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Wolfson Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01178723
First received: August 8, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • blood glucose balance [ Time Frame: three months ] [ Designated as safety issue: No ]
    HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark


Secondary Outcome Measures:
  • 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
Intervention Details:
    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

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178723

Contacts
Contact: Julio Wainstein, M.D 03-5028716 vainstein@wolfson.health.gov.il

Locations
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   
Sponsors and Collaborators
Wolfson Medical Center
  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 August 27, 2014