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| Name | Class |
|---|---|
| Hospital de Clinicas Caracas | OTHER |
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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
In obesity and in type 2 diabetes eating behavior especially the lack of breakfast promote weight gain, increase hunger and carbohydrate craving.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omitted Breakfast | Experimental | 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 |
|
| Breakfast | Active Comparator | The patients in Breakfast day will consume breakfast at 8:00 and then lunch at 13;30 and dinner at 19:00 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omitted Breakfast | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Glucose Response | Postprandial Glucose response will be measure after lunch and dinner | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Insulin Response | Postprandial Insulin response will be measure after lunch and dinner | 12 weeks |
| Postprandial intact-GLP-1 Response | Postprandial intact-GLP-1 response will be measure after lunch and dinner |
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Inclusion Criteria:
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:
13.Work shifts within the last 5 years and did not cross time zones within the last month of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Julio Wainstein, MD | Head of Diabetes Unit E. Wolfson Medical Center Israel | Principal Investigator |
| Daniela Jakubowicz, MD | Hospital de Clinicas Caracas, Venezuela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daniela Jakubowicz | Holon | N/A = Not Applicable | 58100 | Israel | ||
| Daniela Jakubowicz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33512717 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D062408 | Breakfast |
| ID | Term |
|---|---|
| D062407 | Meals |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
| Breakfast | Other | 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: |
|
|
| 12 weeks |
| Postprandial Glucagon Response | Postprandial Glucagon response will be measure after lunch and dinner | 12 weeks |
| Postprandial Free Fatty Acids Response | Postprandial Free Fatty Acids response will be measure after lunch and dinner | 12 weeks |
| Caracas |
| 410 |
| Venezuela |
| D004700 | Endocrine System Diseases |
| D019602 |
| Food and Beverages |