Clinical trial NCT01571310: Effect of Breakfast or Omission of Breakfast in T2D
Official title: Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner in T2D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas Caracas
First posted: 2012-04-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Postprandial Glucose Response
timeFrame: 12 weeks
Secondary outcomes:
measure: Postprandial Insulin Response
timeFrame: 12 weeks
measure: Postprandial intact-GLP-1 Response
timeFrame: 12 weeks
measure: Postprandial Glucagon Response
timeFrame: 12 weeks
measure: Postprandial Free Fatty Acids Response
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Daniela Jakubowicz
state: N/A = Not Applicable
city: Caracas
country: Venezuela
facility: Daniela Jakubowicz
Study officials:
affiliation: Head of Diabetes Unit E. Wolfson Medical Center Israel
name: Julio Wainstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clinicas Caracas, Venezuela
name: Daniela Jakubowicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.