High Calorie Breakfast Versus Fasting in Pre-T2D (BvsNoB)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Daniela Jakubowicz, MD, Hospital de Clinicas Caracas
ClinicalTrials.gov Identifier:
NCT01623648
First received: June 18, 2012
Last updated: June 20, 2015
Last verified: June 2015
  Purpose

The investigators hypothesis is that comparing to eating breakfast, the omission of breakfast will results in higher glucose and insulin response after subsequent lunch and dinner in pre- diabetic women


Condition Intervention
Type 2 Diabetes
Other: Arm 1 Breakfast
Other: Arm 2 No 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 High Calorie Breakfast vs Fasting Until Noon on Potsprandial Glucose and Insulin After Lunch and Dinner in Pre-T2D

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas Caracas:

Primary Outcome Measures:
  • Plasma glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial plasma glucose after lunch and dinner


Secondary Outcome Measures:
  • Plasma Insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial plasma insulin after lunch and dinner

  • intact GLP-1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial plasma intact GLP-1 after lunch and dinner

  • Plasma free fattly acids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Postprandial plasma intact GLP-1 after lunch and dinner

  • Androgen (Free testosterone, Testosterone, DHEA-S, Androstenedione) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Fasting before and after run-in diet


Estimated Enrollment: 30
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Breakfast
The arm 1 will be assigned to eating High calorie breakfast (700kcal), lunch (700 cal) and dinner (700 cal)
Other: Arm 1 Breakfast
The patients will be assigned to eat breakfast (700 kcal) at 8:00, lunch (700 kcal) at 13.30 and dinner (700 kcal) at 19:00
Other Name: YesB
Other: Arm 2 No Breakfast
The patients will fast until lunch, then will eat lunch (700 kcal) at 13.30 and dinner (700 kcal) at 19:00
Other Name: NoB
Experimental: Arm 2: No Breakfast
The arm 2 will be assigned to Fasting until lunch (No Breakfast), lunch (700 cal) and dinner (700 cal)
Other: Arm 1 Breakfast
The patients will be assigned to eat breakfast (700 kcal) at 8:00, lunch (700 kcal) at 13.30 and dinner (700 kcal) at 19:00
Other Name: YesB
Other: Arm 2 No Breakfast
The patients will fast until lunch, then will eat lunch (700 kcal) at 13.30 and dinner (700 kcal) at 19:00
Other Name: NoB

Detailed Description:

Recently we have shown that compared to low carbohydrate diet, an isocaloric diet with addition of high calorie breakfast that also included dessert, promoted sustained weight loss and prevented weight regain by reducing diet-induced compensatory changes in hunger, cravings and ghrelin suppression. However direct effects of meal timing (eating vs non eating breakfast) on the metabolic response after lunch and dinner was not explored in pre-diabetics.

To search whether a change in meal timing by increasing calories in the morning vs fasting until lunch can influence glucose, insulin and intact GLP-1 and response after subsequent isocaloric lunch and dinner

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1.Subjects ≥18 and ≤45 years of age 2.BMI: 26 to 35 kg/m2) 3.Pre-Diabetes criteria

  1. HbA1C: 5.7- 6.4 % or
  2. Fasting Glucose: 100 -125 mg/dl or
  3. OGTT 2h = 140 - 199 mg/dl 5. Habitually eat breakfast 6. Only naïve non treated with oral antidiabetic i.e. metformin. Those with anti-hypertensive and lipid-lowering medication will be included.

    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.Those who provide signed informed consent 11.Stable physical activity pattern during the three months immediately preceding study initiation 12. Normal TSH and FT4 levels 13. Normal liver and kidney function

    Exclusion Criteria:

    1. Diabetes
    2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
    3. Anemia (Hg > 10 g/dL)
    4. Serum creatinine level > 1.5 mg/dl
    5. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
    6. 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
    7. Infectious disease
    8. Malignancy
    9. Pregnant women or lactating
    10. Participating in dietary program or using of weight-loss medications
    11. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
    12. Use of psychotropic or anoretic medication during the month immediately prior to study onset
    13. Did not work shifts within the last 5 years and did not cross time zones within the last month of the study.

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01623648

Locations
Israel
Daniela Jakubowicz
Holon, N/A = Not Applicable, Israel, 58100
Venezuela
Daniela Jakubowicz
Caracas, San Bernardino, Venezuela, 410
Sponsors and Collaborators
Hospital de Clinicas Caracas
Tel Aviv University
Investigators
Principal Investigator: Daniela Jakubowicz, MD Hospital de Clinicas Caracas
  More Information

No publications provided

Responsible Party: Daniela Jakubowicz, MD, MD, Hospital de Clinicas Caracas
ClinicalTrials.gov Identifier: NCT01623648     History of Changes
Other Study ID Numbers: HCCCBI 017-2007-104
Study First Received: June 18, 2012
Last Updated: June 20, 2015
Health Authority: Venezuela: Ethics Committee

Keywords provided by Hospital de Clinicas Caracas:
B
NoB

ClinicalTrials.gov processed this record on July 01, 2015