Effect of Breakfast or Omission of Breakfast in T2D

Type 2 Diabetes Clinical Trial

— OB-B  

Official title:

Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner in T2D

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571310
• Other study ID #: HCCCBI 017-2007-112
• Status: Completed
• Phase: N/A
• First received: March 30, 2012
• Last updated: October 10, 2017
• Start date: July 2012
• Est. completion date: May 2016

Study information

• Verified date: October 2017
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Other:
• 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:

Locations

Country	Name	City	State
Israel	Daniela Jakubowicz	Holon	N/A = Not Applicable
Venezuela	Daniela Jakubowicz	Caracas

Sponsors (2)

Lead Sponsor	Collaborator
Tel Aviv University	Hospital de Clinicas Caracas

Countries where clinical trial is conducted

Israel,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial Glucose Response	Postprandial Glucose response will be measure after lunch and dinner	12 weeks
Secondary	Postprandial Insulin Response	Postprandial Insulin response will be measure after lunch and dinner	12 weeks
Secondary	Postprandial intact-GLP-1 Response	Postprandial intact-GLP-1 response will be measure after lunch and dinner	12 weeks
Secondary	Postprandial Glucagon Response	Postprandial Glucagon response will be measure after lunch and dinner	12 weeks
Secondary	Postprandial Free Fatty Acids Response	Postprandial Free Fatty Acids response will be measure after lunch and dinner	12 weeks