Effect of Breakfast or Omission of Breakfast in T2D (OB-B)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hospital de Clinicas Caracas
Information provided by (Responsible Party):
Daniela Jakubowicz, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT01571310
First received: March 30, 2012
Last updated: April 3, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention
Type 2 Diabetes
Other: Omitted Breakfast
Other: Breakfast

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner in T2D

Resource links provided by NLM:


Further study details as provided by Tel Aviv University:

Primary Outcome Measures:
  • Postprandial Glucose Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial Glucose response will be measure after lunch and dinner


Secondary Outcome Measures:
  • Postprandial Insulin Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial Insulin response will be measure after lunch and dinner

  • Postprandial intact-GLP-1 Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial intact-GLP-1 response will be measure after lunch and dinner

  • Postprandial Glucagon Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial Glucagon response will be measure after lunch and dinner

  • Postprandial Free Fatty Acids Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial Free Fatty Acids response will be measure after lunch and dinner


Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: April 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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
Other Name: Omission of Breakfast
Other: 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:

Other Name: Breakfast consupmtion
Active Comparator: Breakfast
The patients in Breakfast day will consume breakfast at 8:00 and then lunch at 13;30 and dinner at 19:00
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
Other Name: Omission of Breakfast
Other: 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:

Other Name: Breakfast consupmtion

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01571310

Locations
Israel
Daniela Jakubowicz
Holon, N/A = Not Applicable, Israel, 58100
Venezuela
Daniela Jakubowicz
Caracas, Venezuela, 410
Sponsors and Collaborators
Tel Aviv University
Hospital de Clinicas Caracas
Investigators
Principal Investigator: Julio Wainstein, MD Head of Diabetes Unit E. Wolfson Medical Center Israel
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas, Venezuela
  More Information

No publications provided

Responsible Party: Daniela Jakubowicz, Prof. Daniela Jakubowicz MD, Tel Aviv University
ClinicalTrials.gov Identifier: NCT01571310     History of Changes
Other Study ID Numbers: HCCCBI 017-2007-112
Study First Received: March 30, 2012
Last Updated: April 3, 2015
Health Authority: Venezuela: Ethics Committee

ClinicalTrials.gov processed this record on May 21, 2015