Effect of Breakfast or Omission of Breakfast in T2D

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: Omitted Breakfast; Other: Breakfast

• Registration Number: NCT01571310
• Lead Sponsor: Tel Aviv University

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

Study Timeline

• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-05
• Study Start: 2012-07
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

12. Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00.

13. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Breakfast	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	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
Breakfast	Omitted 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	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

Primary Outcome Measures

Name	Time	Method
Postprandial Glucose Response	12 weeks	Postprandial Glucose response will be measure after lunch and dinner

Secondary Outcome Measures

Name	Time	Method
Postprandial Insulin Response	12 weeks	Postprandial Insulin response will be measure after lunch and dinner
Postprandial intact-GLP-1 Response	12 weeks	Postprandial intact-GLP-1 response will be measure after lunch and dinner
Postprandial Glucagon Response	12 weeks	Postprandial Glucagon response will be measure after lunch and dinner
Postprandial Free Fatty Acids Response	12 weeks	Postprandial Free Fatty Acids response will be measure after lunch and dinner

Trial Locations

Locations (1)

Daniela Jakubowicz; 🇻🇪 Caracas, Venezuela