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Completed

NCT Number: NCT01571310

Effect of Breakfast or Omission of Breakfast in T2D

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

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Key information

Age range

30 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Daniela Jakubowicz, Holon, N/A = Not Applicable, Israel

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetics for < 10yr
  • HbA1C: 7-9 %
  • BMI: 22 to 35 kg/m2)
  • Age: ≥30 and ≤70 years of age
  • Habitually eat breakfast
  • Naïve or treated with oral antidiabetic drugs and those with anti-hypertensive and lipid-lowering medication
  • Those treated with insulin or GLP-1 analogs or having major liver, heart or kidney illnesses will be excluded.
  • Usually wake up between 06:00 and 07:00 and go to sleep between 22:00 and 24:00.
  • Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months
  • Stable physical activity pattern during the three months immediately preceding study initiation
  • Normal liver and kidney function 12 No metabolic disease other then diabetes
  • Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:00.
  • 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

  • Type 1 diabetes
  • Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
  • 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
  • Anemia (Hg > 10g/dL)
  • Serum creatinine level > 1.5 mg/dl
  • Pregnant or lactating
  • Participating in another dietary program or use of weight-loss medications
  • Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
  • 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.

Treatment and study plan

Omitted Breakfast

Other

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 names: Omission of Breakfast

Breakfast

Other

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 names: Breakfast consupmtion

Primary outcomes

  1. Postprandial Glucose Response

    Time frame: 12 weeks

    Postprandial Glucose response will be measure after lunch and dinner

Secondary outcomes

  1. Postprandial Insulin Response

    Time frame: 12 weeks

    Postprandial Insulin response will be measure after lunch and dinner

  2. Postprandial intact-GLP-1 Response

    Time frame: 12 weeks

    Postprandial intact-GLP-1 response will be measure after lunch and dinner

  3. Postprandial Glucagon Response

    Time frame: 12 weeks

    Postprandial Glucagon response will be measure after lunch and dinner

  4. Postprandial Free Fatty Acids Response

    Time frame: 12 weeks

    Postprandial Free Fatty Acids response will be measure after lunch and dinner

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Collaborators

  • Hospital de Clinicas Caracas

Registry information

Official study title

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

Acronym: OB-B

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 5, 2012
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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