Effect of Breakfast or Omission of Breakfast in T2D

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01571310
• Date of registration: 30/03/2012
• Prospective Registration: Yes
• Primary sponsor: Tel Aviv University
• Public title: Effect of Breakfast or Omission of Breakfast in T2D OB-B
• Scientific title: Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner in T2D
• Date of first enrolment: July 2012
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01571310
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Israel, Venezuela

Contacts

• Name: Julio Wainstein, MD
• Affiliation: Head of Diabetes Unit E. Wolfson Medical Center Israel

• Name: Daniela Jakubowicz, MD
• Affiliation: Hospital de Clinicas Caracas, Venezuela

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Other: Omitted Breakfast

Other: Breakfast

Primary Outcome(s)

Postprandial Glucose Response [Time Frame: 12 weeks]

Secondary Outcome(s)

Postprandial Insulin Response [Time Frame: 12 weeks]

Postprandial Glucagon Response [Time Frame: 12 weeks]

Postprandial Free Fatty Acids Response [Time Frame: 12 weeks]

Postprandial intact-GLP-1 Response [Time Frame: 12 weeks]

Secondary ID(s)

HCCCBI 017-2007-112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hospital de Clinicas Caracas