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

August 8, 2010 updated by: Wolfson Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Preliminary results of clinical research (unpublished) show a connection between a large breakfast and weight loss and increased feeling of satiety throughout the day.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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood glucose balance
Time Frame: three months
HBA1C, C-peptid, insulin, glucose, HOMA-IR, Glycomark
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anthropometric parameters
Time Frame: three months
weight, height, body composition
three months
Adipokines and hormones
Time Frame: three months
insulin, leptin, ghrelin, adiponectin, GLP-1, cortisol
three months
pro-inflammatory cytokines
Time Frame: three months
TNF-α, IL-6, MCP-1, CRP
three months
lipid profile
Time Frame: three months
triglycerides, cholesterol, LDL, HDL
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 8, 2010

First Submitted That Met QC Criteria

August 8, 2010

First Posted (Estimate)

August 10, 2010

Study Record Updates

Last Update Posted (Estimate)

August 10, 2010

Last Update Submitted That Met QC Criteria

August 8, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC10JW0080CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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