Eating vs Skipping Breakfast on Postprandial Hyperglycemia After Lunch and Dinner in T2D (SkippB-T2D)

June 2, 2015 updated by: Daniela Jakubowicz, Tel Aviv University

Effect of Eating vs Skipping Breakfast on Postprandial Hyperglycemia After Subsequent Isocaloric Lunch and Dinner in Type 2 Diabetic Patients

Background: Skipping breakfast and/or overeating at evening, has been associated in type 2 diabetic (T2D) individuals, with higher BMI, visceral adiposity, hyperlipidemia, increased overall postprandial glycemia (PPHG) and higher HbA1c. The absence of breakfast is also associated with increased plasma free fatty acids (FFA) along the morning until lunch. High plasma FFA in turn are triggering factor of insulin resistance, by inhibiting insulin mediated glucose uptake in obese and T2D subjects The investigators therefore hypothesize that compared to eating breakfast the prolonged overnight fasting caused by the breakfast omission will result in increased postprandial glycemic response after subsequent isocaloric lunch and dinner in T2D individuals.

Objectives: With this aim will study T2D patients in randomized crossover design to consume in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition (YesB) or omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner with the same caloric content.

Methods and Study Design: The YesB intervention will consist on three identical meals coating 700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB intervention the breakfast will be omitted and the subject continue fasting until lunch. Then the participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at 19:00. The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with blood samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at the same time point the blood samples will be collected after 8:00 when the breakfast will be omitted.

Expected results: The investigators expect that compared to NoB condition, in the YesB condition the postprandial response after lunch and dinner will be reduced for glucose and for FFA, while plasma insulin, C-peptide and GLP-1 postprandial response after lunch and dinner will be enhanced

Study Overview

Status

Unknown

Conditions

Detailed Description

Background or Rationale Studies analyzing the postprandial glycemic response have shown that glucose tolerance display a clear diurnal variation with a progressive decline in carbohydrate tolerance toward the evening hours with more prolonged and higher postprandial glycemic response in the evening than in the morning.

Meal timing patterns, on the other hand, exerts strong entraining influence on clock gene regulation of hormones and enzymes i.e. insulin, GLP-1, involved in glucose metabolism and postprandial glycemia disrupting the diurnal variation of postprandial glycemia (PPG). It suggests the extent of post-prandial rise in plasma glucose depends not only upon the quantity and nature of food ingested, and on the clock gene regulated circadian hormonal rhythms, it also depends upon the metabolic state immediately prior to eating. Indeed, meal schedule non-aligned with the clock gene circadian rhythms, such as skipping breakfast and/or overeating at evening, has been associated, in T2D individuals, with higher BMI, visceral adiposity, hyperlipidemia, higher HbA1c and increased PPG despite same caloric intake. The absence of breakfast has been associated in obese and T2D subjects with increased plasma levels of free fatty acids (FFA) along the morning until the lunch, Chronic and acute increase of FFA plasma levels, has been reported as triggering factor of insulin resistance, by inhibition of insulin mediated stimulated glucose uptake and/or phosphorylation which develops 3-4 hours after raising of plasma FFA and by inhibition of glycogen synthase, the rate limiting enzyme of glycogen synthesis, which develops 4-6 hours after the rise of FFA. However the effect of eating vs skipping breakfast on postprandial glucose response after identical lunch and dinner has not been explored. It is therefore important to explore the influence of eating versus skipping breakfast on postprandial glucose, after lunch and dinner in T2D individuals. Concomitantly the investigators will assess after lunch and dinner plasma insulin, GLP-1 and FFA response after lunch and dinner in T2D individuals.

Expected results: The investigators expect that compared skipping breakfast condition, the eating breakfast condition will reduce postprandial plasma glucose and FFA response after lunch and dinner, while plasma insulin, C-peptide and GLP-1 after lunch and dinner will be enhanced Relevance of the study: If our hypothesis is confirmed it may be may be of practical benefit to people with Type 2 diabetes, a condition in which the reduction of PPHG at lunch and at dinner may result in improved HbA1c and might be also preventive of the risk for CVD Objectives: With this aim will study T2D patients in randomized crossover design to consume in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition (YesB) or omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner with the same caloric content.

Methods and Study Design: The YesB intervention will consist on three identical meals coating 700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB intervention the breakfast will be omitted and the subject continue fasting until lunch. Then the participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at 19:00. The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with blood samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at the same time point the blood samples will be collected after 8:00 when the breakfast will be omitted.

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact Backup

Study Locations

    • Tel Aviv
      • Holon, Tel Aviv, Israel, 58100
        • Recruiting
        • Diabetes Unit E. Wolfson Medical center
        • Contact:
        • Principal Investigator:
          • Daniela Jakubowicz, MD
        • Contact:

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:

  • T2D since < 10 yrs, with HbA1c > 7 % and BMI: 26-34 kg/m2.
  • Only naïve or treated with oral antidiabetic drugs and with anti-hypertensive and lipid-lowering medication will be included.
  • Those treated with insulin or GLP-1 analogs or having major liver, heart or kidney illnesses will be excluded.

Exclusion Criteria:

  1. Type 1 DM, secondary DM, gestational DM
  2. Patients using insulin, TZDs
  3. Patients using corticosteroid, herb medication or other medications affecting glucose tolerance
  4. Renal dysfunction (Cr > 1.5mg/dL)
  5. Hepatic dysfunction (LFT > x 3UNL)
  6. Anemia (Hg > 10g/dL)
  7. Ischemic heart disease, congestive heart failure
  8. Severe diabetic complication (CRF, CVA, PDR, gastroparesis)
  9. Infectious disease
  10. Malignancy
  11. Pregnant women

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skipping Breakfast (NoB)
The patients in No B will omit the breakfast and will continue the overnight fast until lunch. Will eat only lunch and dinner. In YesB will eat all three meals
NoB: The patients will omit the breakfast, will continue the overnight fast until lunch, then will eat only lunch and dinner.
Other Names:
  • omitting breakfast
Active Comparator: Eating Breakfast (YesB):
The patients in YesB will eat all three mealswill consume three meals: breakfast, lunch and dinner
YesB: will eat all three meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of plasma glucose
Time Frame: 5 weeks
Postprandial glycemia
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure of plasma Insulin
Time Frame: 5 weeks
5 weeks
Measure of plasma GLP-1
Time Frame: 5 weeks
5 weeks
Measure of free fatty acids (FFA)
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Daniela Jakubowicz, MD, Diabetes Unit E. Wolfson Medical center Holon, Tel Aviv Israe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

April 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

November 2, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Estimate)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 0160-14-WOMC

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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