Effect of Breakfast or Omission of Breakfast in T2D
OB-B
Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner in T2D
1 other identifier
interventional
30
2 countries
2
Brief Summary
The investigators will explore the effect of omission of breakfast on postprandial hyperglycemia and insulin and intact GLP-1 response after subsequent meals in type 2 diabetic patients
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 Jul 2012
Longer than P75 for not_applicable type-2-diabetes
2 active sites
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
First Submitted
Initial submission to the registry
March 30, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedOctober 11, 2017
October 1, 2017
3.8 years
March 30, 2012
October 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Postprandial Glucose Response
Postprandial Glucose response will be measure after lunch and dinner
12 weeks
Secondary Outcomes (4)
Postprandial Insulin Response
12 weeks
Postprandial intact-GLP-1 Response
12 weeks
Postprandial Glucagon Response
12 weeks
Postprandial Free Fatty Acids Response
12 weeks
Study Arms (2)
Omitted Breakfast
EXPERIMENTALExperimental: The patients in Omitted Breakfast day will omit the breakfast and will continue the fast until noon. Thereafter will eat Lunch at 13;30 and Dinner at 19:00
Breakfast
ACTIVE COMPARATORThe patients in Breakfast day will consume breakfast at 8:00 and then lunch at 13;30 and dinner at 19:00
Interventions
Experimental:The patients in Omitted Breakfast day will omit the breakfast and will continue the overnight fast until lunch. They will eat only lunch (700 kcal) at 13:30 and dinner (700 kcal) at 19:00
In the Active Comparator: The patients in the Breakfast day will consume breakfast (700 kcal) at 8:00 , lunch (700 kcal) at 13:30 and dinner (700 kcal) at 19:00 (YesB): The patients in YesB will eat all three mealswill consume three meals:
Eligibility Criteria
You may qualify if:
- Type 2 diabetics for \< 10yr
- HbA1C: 7-9 %
- BMI: 22 to 35 kg/m2)
- Age: ≥30 and ≤70 years of age
- Habitually eat breakfast
- Naïve or treated with oral antidiabetic drugs and those with anti-hypertensive and lipid-lowering medication
- Those treated with insulin or GLP-1 analogs or having major liver, heart or kidney illnesses will be excluded.
- Usually wake up between 06:00 and 07:00 and go to sleep between 22:00 and 24:00.
- Not dieting and no change in body weight \>10 lb = 4.5 kg within the last 6 months
- Stable physical activity pattern during the three months immediately preceding study initiation
- Normal liver and kidney function 12 No metabolic disease other then diabetes
- \. Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00.
- \. Normal TSH and FT4 levels 16. Acceptable health based on interview, medical history, physical examination, and laboratory tests 17. Those who provide signed informed consent
You may not qualify if:
- Type 1 diabetes
- Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
- Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
- Anemia (Hg \> 10g/dL)
- Serum creatinine level \> 1.5 mg/dl
- Pregnant or lactating
- Participating in another dietary program or use of weight-loss medications
- Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
- Use of psychotropic or anoretic medication during the month immediately prior to study onset
- Work shifts within the last 5 years and did not cross time zones within the last month of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel Aviv Universitylead
- Hospital de Clinicas Caracascollaborator
Study Sites (2)
Daniela Jakubowicz
Holon, N/A = Not Applicable, 58100, Israel
Daniela Jakubowicz
Caracas, 410, Venezuela
Related Publications (1)
Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PMID: 33512717DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julio Wainstein, MD
Head of Diabetes Unit E. Wolfson Medical Center Israel
- PRINCIPAL INVESTIGATOR
Daniela Jakubowicz, MD
Hospital de Clinicas Caracas, Venezuela
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Daniela Jakubowicz MD
Study Record Dates
First Submitted
March 30, 2012
First Posted
April 5, 2012
Study Start
July 1, 2012
Primary Completion
April 1, 2016
Study Completion
May 1, 2016
Last Updated
October 11, 2017
Record last verified: 2017-10