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

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ClinicalTrials.gov Identifier: NCT01571310
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
Hospital de Clinicas Caracas
Information provided by (Responsible Party):
Daniela Jakubowicz, Tel Aviv University

Tracking Information
First Submitted Date  ICMJE March 30, 2012
First Posted Date  ICMJE April 5, 2012
Last Update Posted Date October 11, 2017
Actual Study Start Date  ICMJE July 2012
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
Postprandial Glucose Response [ Time Frame: 12 weeks ]
Postprandial Glucose response will be measure after lunch and dinner
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2012)
Change in Body Weight [ Time Frame: Change in Body weight every 2 weeks until week 12 ]
Body weight will be measured at baseline and every 2 weeks until week 12 at the end of the trial
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2015)
  • Postprandial Insulin Response [ Time Frame: 12 weeks ]
    Postprandial Insulin response will be measure after lunch and dinner
  • Postprandial intact-GLP-1 Response [ Time Frame: 12 weeks ]
    Postprandial intact-GLP-1 response will be measure after lunch and dinner
  • Postprandial Glucagon Response [ Time Frame: 12 weeks ]
    Postprandial Glucagon response will be measure after lunch and dinner
  • Postprandial Free Fatty Acids Response [ Time Frame: 12 weeks ]
    Postprandial Free Fatty Acids response will be measure after lunch and dinner
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2012)
Plasma Ghrelin Levels [ Time Frame: Ghrelin levels at baseline and after 12 weeks ]
Ghrelin plasma levels will be measured after breakfast and after dinner at baseline and after 12 week on diet
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Breakfast or Omission of Breakfast in T2D
Official Title  ICMJE Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner in T2D
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: Omitted Breakfast
    • Other: Breakfast
  • 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
    Interventions:
    • Other: Omitted Breakfast
    • Other: Breakfast
Publications * 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:CD013496. doi: 10.1002/14651858.CD013496.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2015)
30
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2012)
90
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01571310
Other Study ID Numbers  ICMJE HCCCBI 017-2007-112
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Daniela Jakubowicz, Tel Aviv University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tel Aviv University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hospital de Clinicas Caracas
Investigators  ICMJE
Principal Investigator: Julio Wainstein, MD Head of Diabetes Unit E. Wolfson Medical Center Israel
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas, Venezuela
PRS Account Tel Aviv University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP