Meal Timing on Postprandial Glucose, Insulin and GLP-1 in Type 2 Diabetes (GLP-1inT2D)

November 6, 2013 updated by: Daniela Jakubowicz, Tel Aviv University

Effects of Meal Timing on Postprandial Glucose, Insulin and GLP-1 Responses After Breakfast Lunch and Dinner in Patients With Type 2 Diabetes

Enhanced insulin and GLP-1 postprandial response after morning meal versus evening meal, might be underlying explanation of the beneficial effect of eating breakfast with reduced dinner vs skipping breakfast on glycemic control and HbA1c in T2D patients.

To test this hypothesis and clarify whether glucose, insulin and GLP-1 postprandial responses are different in the morning vs. in the afternoon, the investigators will compare in T2D subjects in random order and in two separate days: the glucose, insulin and GLP-1 postprandial responses after breakfast, lunch and dinner with 2 isocaloric meal plans or test diets, that differ in meal timing distribution The investigators hypothesize that GLP-1 and insulin response after high calorie breakfast will be higher in comparison to GLP-1 and insulin response after identical meal at evening

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The endogenous circadian (24-h) timing system, synchronized by light/dark cycle in the master circadian clock in the suprachiasmatic nuclei and by meal timing in the peripheral clock genes; plays a significant role in regulating sleep/wake and feeding behavior, body weight as well as glucose and lipid metabolism.

Circadian misalignment, involving sleep/wake and meal timing schedules 12 h out of phase from their habitual times resulted in elevated blood pressure and increased postprandial glucose and insulin levels. Animal models of circadian misalignment specially breakfast skipping are associated with alteration in the expression pattern of clock genes such as Clock, Bmal1, Cry1, and Per2 in the liver and fat cells. These changes resulted in a predisposition to obesity and type 2 diabetes (T2D). This may also explain why evening or night eating is often associated with weight gain and obesity.

Breakfast skipping has been consistently associated with increased, visceral adiposity, higher BMI and waist circumference, insulin resistance, dyslipidemia and with T2D despite having less total daily caloric intake.

A recent population-based studies have found that participants with an evening preferences (late chronotype) that involves breakfast skipping, have 2.5 times risk of developing T2D, even after adjustment for body mass index (BMI) (12).

Breakfast skipping and greater percentage of their daily caloric intake at dinner was associated with higher fasting plasma glucose levels, and poorer glycemic control compared with earlier chronotypes even after adjusting for BMI (11,20,21). Recently was documented that in T2D patients, breakfast skipping was associated was associated with a 10.8% increase in HbA1C of its original value, even after adjusting for age, sex, race, BMI, number of diabetes complications, insulin use, depressive symptoms, perceived sleep debt, and percentage of daily caloric intake at dinner. This significant difference in HbA1C levels between breakfast skippers and breakfast eaters in patients with T2D, highlights the potential impact of the meal timing on the course of the disease.

More recently the investigators documented that compared to a conventional diet, a high caloric intake in the breakfast and reduced dinner resulted in significant reduction of HbA1c in T2D individuals.

The existence of diurnal variation in glucose tolerance in healthy and in subjects with T2D has been suspected for decades, with reports showing that glucose tolerance decreases progressively throughout the day with insulin sensitivity reaching a nadir in the evening. The reduction of glucose tolerance in the evening, seems to be a results from a combination of reduced glucose utilization, decreased insulin sensitivity, and inappropriately low insulin secretion and action, which highlights the importance of meal timing in glucose metabolism.

It is known that insulin response to meal ingestion is more rapid in the morning than in the afternoon and specifically the early (30 or 45 min) insulin secretion after oral glucose or meal ingestion is significantly higher in the morning than in the evening. A possible explanation for the more rapid glucose clearance from the circulation in the morning is because the early insulin response is important for rapid reduction in hepatic glucose output after meal ingestion.

Recently was shown that the enhanced early (30-min) insulin secretion after morning meal vs. afternoon, was accompanied by a correspondingly faster incretin total GLP-1 and intact GLP-1 hormone response in the morning specially during the first 30 min after ingestion. The association was consistent and also supports the prediction that higher GLP-1 levels after morning meal would result in a higher potentiation of β-cell function.

This diurnal pattern of enhanced insulin and GLP-1 response after morning meal versus in the evening, might be underlying explanation of the beneficial effect of eating breakfast with reduced dinner vs skipping breakfast on glycemic control and HbA1c in T2D patients.

To test this hypothesis the investigators will compare in random order and in two separate days: the glucose, insulin and GLP-1 postprandial responses after breakfast, lunch and dinner with 2 isocaloric meal plans or test diets, that differ only in meal timing distribution

  1. High caloric breakfast, average lunch and reduced dinner (BTdiet) and
  2. High caloric dinner, similar lunch and reduced breakfast (DTdiet)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Israel
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Type 2 diabetes patients
  2. HbA1C > 7%
  3. Duration of diabetes: 0.5 to 10 years
  4. Subjects ≥ 30 and ≤70 years of age
  5. BMI: 22 to 35 kg/m2
  6. Diet controlled diabetic. Only treatment with metformin will be allowed
  7. Normal liver and kidney function
  8. Normal thyroid function
  9. Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
  10. Stable physical activity pattern during the three months immediately preceding study
  11. Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
  12. No shift work within 5 years of the study
  13. Did not cross time zones within 1 month of the study
  14. Read and understood the informed consent form and signed it voluntarily

Exclusion Criteria:

  1. Type 1 diabetes
  2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
  3. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
  4. Pregnancy or lactation
  5. Illicit drug abuse or alcoholism
  6. Treatment with antidiabetic drugs, insulin or GLP-1 analogs
  7. Subjects taking anoretic drugs during the month immediately prior to study
  8. Subjects on steroid treatment
  9. Those with eating disorders
  10. Subjects after bariatric surgery, will be excluded

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Calorie Breakfast (BTdiet)
High Calorie Breakfast (BTdiet): The subject will consume High caloric breakfast, average lunch and reduced in calories dinner (BTdiet)
Other: High Calorie Breakfast (BTdiet)
High Caloric Breakfast Test Diet (BTdiet): in which the majority of energy load will be consumed in the morning and with reduced dinner
Active Comparator: High Calorie Dinner (DTdiet)
High Calorie Dinner (DTdiet): The subject will consume High caloric dinner, average lunch and reduced in calories breakfast (DTdiet)
Other: High Caloric Dinner (DTdiet)
High Caloric Dinner (DTdiet): resembling a skipping breakfast plan, in which the majority of energy load will be consumed in the evening with minimal caloric content at breakfast

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postprandial GLP-1 plasma levels, after breakfast,lunch and dinner meal test
Time Frame: During 3 hours after breakfast, lunch and dinner meal challange
All Type 2 diabetic participants will be randomly assigned to one of 2 isocaloric diet sequences that will differ in the meal timing distribution. The diets will be tested in two separate occasions during a curse of a single day (test day) in which postprandial plasma GLP-1 levels during 3 hours after breakfast, lunch and dinner meal challenge will be measured
During 3 hours after breakfast, lunch and dinner meal challange

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postprandial Plasma Glucose levels after breakfast, lunch and dinner meal challenge
Time Frame: Postprandial Plasma Glucose levels during 3 hours after breakfast, lunch and dinner meal challenge
All Type 2 diabetic participants will be randomly assigned to one of 2 isocaloric diet sequences that will differ in the meal timing distribution. The diets will be tested in two separate occasions during a curse of a single day (test day) in which postprandial plasma Glucose levels during 3 hours after breakfast, lunch and dinner meal challenge will be measured
Postprandial Plasma Glucose levels during 3 hours after breakfast, lunch and dinner meal challenge

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postprandial Insulin plasma levels, after breakfast,lunch and dinner meal test
Time Frame: During 3 hours, after breakfast,lunch and dinner meal test
All Type 2 diabetic participants will be randomly assigned to one of 2 isocaloric diet sequences that will differ in the meal timing distribution. The diets will be tested in two separate occasions during a curse of a single day (test day) in which postprandial plasma Insulin levels during 3 hours after breakfast, lunch and dinner meal challenge will be measured
During 3 hours, after breakfast,lunch and dinner meal test

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tel Aviv University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wolfson Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniela Jakubowicz, E. Wolfson Medical Center. Tel Aviv University

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.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

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  • 0145-13-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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