Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2012-07-31
2016-05-31
Brief Summary
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Detailed Description
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The present study is designed to address whether in T2D, a change in meal timing; specifically, by adding calories, protein and carbohydrates to the breakfast vs.the omission of breakfast will influence the postprandial elevation of glucose, insulin, intact GLP-1, glucagon and free fatty acids (FFA) after subsequent meals at lunch and dinner.
The investigators expect that compared to the day with breakfast condition the day when the breakfast will be omitted the postprandial glucose , free fattly acids, and glucagon response after lunch and dinner will be significative higher while insulin and intact GLP-1 response after lunch and dinner will be reduced
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Omitted Breakfast
Experimental: 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
Omitted Breakfast
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
Breakfast
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:
Breakfast
The patients in Breakfast day will consume breakfast at 8:00 and then lunch at 13;30 and dinner at 19:00
Omitted Breakfast
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
Breakfast
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:
Interventions
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Omitted Breakfast
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
Breakfast
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:
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. HbA1C: 7-9 %
3. BMI: 22 to 35 kg/m2)
4. Age: ≥30 and ≤70 years of age
5. Habitually eat breakfast
6. Naïve or treated with oral antidiabetic drugs and those with anti-hypertensive and lipid-lowering medication
7. Those treated with insulin or GLP-1 analogs or having major liver, heart or kidney illnesses will be excluded.
8. Usually wake up between 06:00 and 07:00 and go to sleep between 22:00 and 24:00.
9. Not dieting and no change in body weight \>10 lb = 4.5 kg within the last 6 months
10. Stable physical activity pattern during the three months immediately preceding study initiation
11. Normal liver and kidney function 12 No metabolic disease other then diabetes
13\. Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00.
15\. 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
Exclusion Criteria
2. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
3. 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
4. Anemia (Hg \> 10g/dL)
5. Serum creatinine level \> 1.5 mg/dl
6. Pregnant or lactating
7. Participating in another dietary program or use of weight-loss medications
8. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
9. Use of psychotropic or anoretic medication during the month immediately prior to study onset
13.Work shifts within the last 5 years and did not cross time zones within the last month of the study.
30 Years
70 Years
FEMALE
Yes
Sponsors
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Hospital de Clinicas Caracas
OTHER
Tel Aviv University
OTHER
Responsible Party
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Daniela Jakubowicz
Prof. Daniela Jakubowicz MD
Principal Investigators
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Julio Wainstein, MD
Role: PRINCIPAL_INVESTIGATOR
Head of Diabetes Unit E. Wolfson Medical Center Israel
Daniela Jakubowicz, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clinicas Caracas, Venezuela
Locations
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Daniela Jakubowicz
Holon, N/A = Not Applicable, Israel
Daniela Jakubowicz
Caracas, , Venezuela
Countries
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References
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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.
Other Identifiers
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HCCCBI 017-2007-112
Identifier Type: -
Identifier Source: org_study_id