Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments omitted breakfast, breakfast
Sponsor Tel Aviv University
Collaborator Hospital de Clinicas Caracas
Start date July 2012
End date April 2016
Trial size 30 participants
Trial identifier NCT01571310, HCCCBI 017-2007-112

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose diagnostic
Arm
(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
omitted breakfast Omission of 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 Breakfast consupmtion
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:
(Active Comparator)
The patients in Breakfast day will consume breakfast at 8:00 and then lunch at 13;30 and dinner at 19:00
omitted breakfast Omission of 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 Breakfast consupmtion
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:

Primary Outcomes

Measure
Postprandial Glucose Response
time frame: 12 weeks

Secondary Outcomes

Measure
Postprandial Insulin Response
time frame: 12 weeks
Postprandial intact-GLP-1 Response
time frame: 12 weeks
Postprandial Glucagon Response
time frame: 12 weeks
Postprandial Free Fatty Acids Response
time frame: 12 weeks

Eligibility Criteria

Female participants from 30 years up to 70 years old.

Inclusion Criteria: 1. Type 2 diabetics for < 10yr 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: 1. Type 1 diabetes 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.

Additional Information

Official title Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner in T2D
Principal investigator Julio Wainstein, MD
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Tel Aviv University.