Meal Timing on Postprandial Glucose, Insulin and GLP-1 in Type 2 Diabetes
GLP-1inT2D
Effects of Meal Timing on Postprandial Glucose, Insulin and GLP-1 Responses After Breakfast Lunch and Dinner in Patients With Type 2 Diabetes
1 other identifier
interventional
30
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Oct 2013
Shorter than P25 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 31, 2013
CompletedFirst Posted
Study publicly available on registry
November 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedNovember 7, 2013
October 1, 2013
2 months
October 31, 2013
November 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postprandial GLP-1 plasma levels, 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 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 Outcomes (1)
Postprandial Plasma Glucose levels after breakfast, lunch and dinner meal challenge
Postprandial Plasma Glucose levels during 3 hours after breakfast, lunch and dinner meal challenge
Other Outcomes (1)
Postprandial Insulin plasma levels, after breakfast,lunch and dinner meal test
During 3 hours, after breakfast,lunch and dinner meal test
Study Arms (2)
High Calorie Breakfast (BTdiet)
EXPERIMENTALHigh Calorie Breakfast (BTdiet): The subject will consume High caloric breakfast, average lunch and reduced in calories dinner (BTdiet)
High Calorie Dinner (DTdiet)
ACTIVE COMPARATORHigh Calorie Dinner (DTdiet): The subject will consume High caloric dinner, average lunch and reduced in calories breakfast (DTdiet)
Interventions
High Caloric Breakfast Test Diet (BTdiet): in which the majority of energy load will be consumed in the morning and with reduced dinner
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
Eligibility Criteria
You may qualify if:
- Type 2 diabetes patients
- HbA1C \> 7%
- Duration of diabetes: 0.5 to 10 years
- Subjects ≥ 30 and ≤70 years of age
- BMI: 22 to 35 kg/m2
- Diet controlled diabetic. Only treatment with metformin will be allowed
- Normal liver and kidney function
- Normal thyroid function
- Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
- Stable physical activity pattern during the three months immediately preceding study
- Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
- No shift work within 5 years of the study
- Did not cross time zones within 1 month of the study
- Read and understood the informed consent form and signed it voluntarily
You may not qualify if:
- Type 1 diabetes
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
- 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)
- Pregnancy or lactation
- Illicit drug abuse or alcoholism
- Treatment with antidiabetic drugs, insulin or GLP-1 analogs
- Subjects taking anoretic drugs during the month immediately prior to study
- Subjects on steroid treatment
- Those with eating disorders
- Subjects after bariatric surgery, will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel Aviv Universitylead
- Wolfson Medical Centercollaborator
Study Sites (1)
Diabetes Unit E. Wolfson Medical center
Holon, Tel Aviv, 58100, Israel
Related Publications (1)
Jakubowicz D, Wainstein J, Ahren B, Bar-Dayan Y, Landau Z, Rabinovitz HR, Froy O. High-energy breakfast with low-energy dinner decreases overall daily hyperglycaemia in type 2 diabetic patients: a randomised clinical trial. Diabetologia. 2015 May;58(5):912-9. doi: 10.1007/s00125-015-3524-9. Epub 2015 Mar 1.
PMID: 25724569DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Jakubowicz
E. Wolfson Medical Center. Tel Aviv University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Daniela Jakubowicz MD
Study Record Dates
First Submitted
October 31, 2013
First Posted
November 7, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2013
Study Completion
January 1, 2014
Last Updated
November 7, 2013
Record last verified: 2013-10