Breakfast on Postprandial Hyperglycemia (B-PPHG)

April 7, 2015 updated by: Daniela Jakubowicz, MD, Hospital de Clinicas Caracas

Effect of Breakfast on Overall Postprandial Hyperglycemia in T2D

Reduction of postprandial hyperglycemia (PPHG) is a major target in the treatment of type 2 diabetes (T2D). Skipping breakfast has been consistently associated with higher HbA1c and overall PPHG in subjects with type 2 diabetes (T2D). Our aim was to explore the effect of skipping vs eating breakfast on PPHG after subsequent isocaloric (700kcal) lunch and dinner

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In type 2 diabetic individuals the omission of breakfast is associated with significant increase in HbA1C and all-day postprandial hyperglycemia even without overeating in the evening. In contrast, high-energy breakfast and low-energy dinner result in a significant reduction of all-day postprandial glycaemia Similarly, 3 months of high-energy breakfast led to a 5% reduction in HbA1C levels in type 2 diabetes participants Despite the growing evidence showing the beneficial effects of breakfast consumption on overall postprandial hyperglycemia and HbA1C levels, very little is known regarding the relationship between breakfast skipping and all-day glycemic excursions in type 2 diabetes patients. Therefore, to test whether breakfast skipping influences metabolic responses to the following meals in type 2 diabetes patients during the same day, we explored the postprandial glycemic response to identical lunch and dinner meal tests with or without breakfast.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

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:

  • BMI: 26-34 kg/m2.
  • HbA1c > 7 %
  • T2D since < 10 yrs,
  • . Only non treated or treated with oral antidiabetic drugs
  • Those treated with insulin or GLP-1 analogs will be excluded.

Exclusion Criteria:

  • Type 1 diabetes
  • Serum creatinine level > 1.5 mg/dl
  • Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications,such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or anemia (Hg > 10g/dL) or underwent bariatric surgery.
  • Abnormal liver function tests
  • Participating in dietary program or using of weight-loss medications
  • History (within one year) of illicit drug abuse or alcoholism.
  • Use of psychotropic or anoretic medication during the month immediately prior to study onset

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: YesB
On YesB day the patients will consume breakfast , lunch and dinner
Other: Breakfast eating (YesB)
On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00
Other: Breakfast skipping (NoB)
On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00
Experimental: NoB
On NoB Day The patient will consume only lunch and dinner
Other: Breakfast eating (YesB)
On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00
Other: Breakfast skipping (NoB)
On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial Glucose
Time Frame: 6 weeks
Postprandial Glucose will be measure after lunch and dinner
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial intact GLP-1
Time Frame: 6 weeks
Postprandial intact GLP-1 will be measure after lunch and dinner
6 weeks
Postprandial Insulin
Time Frame: 6 weeks
Postprandial Insulin will be measure after lunch and dinner
6 weeks
Postprandial Glucagon
Time Frame: 6 weeks
Postprandial Glucagon will be measure after lunch and dinner
6 weeks
Postprandial Free Fatty Acids
Time Frame: 6 weeks
Postprandial Free Fatty Acids will be measure after lunch and dinner
6 weeks

Collaborators and Investigators

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

Sponsor

Hospital de Clinicas Caracas

Collaborators

Tel Aviv University

Investigators

  • Principal Investigator: Daniela Jakubowicz, MD, Hospital de Clínicas Caracas
  • Principal Investigator: Daniela Jakubowicz, MD, E. Wolfson Medical Center. Israel

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 Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Anticipated)

April 1, 2015

Study Registration Dates

First Submitted

April 3, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCCBI 057-2013-254

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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