Eating vs Skipping Breakfast on Postprandial Hyperglycemia After Lunch and Dinner in T2D
SkippB-T2D
Effect of Eating vs Skipping Breakfast on Postprandial Hyperglycemia After Subsequent Isocaloric Lunch and Dinner in Type 2 Diabetic Patients
1 other identifier
interventional
30
1 country
1
Brief Summary
Background: Skipping breakfast and/or overeating at evening, has been associated in type 2 diabetic (T2D) individuals, with higher BMI, visceral adiposity, hyperlipidemia, increased overall postprandial glycemia (PPHG) and higher HbA1c. The absence of breakfast is also associated with increased plasma free fatty acids (FFA) along the morning until lunch. High plasma FFA in turn are triggering factor of insulin resistance, by inhibiting insulin mediated glucose uptake in obese and T2D subjects The investigators therefore hypothesize that compared to eating breakfast the prolonged overnight fasting caused by the breakfast omission will result in increased postprandial glycemic response after subsequent isocaloric lunch and dinner in T2D individuals. Objectives: With this aim will study T2D patients in randomized crossover design to consume in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition (YesB) or omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner with the same caloric content. Methods and Study Design: The YesB intervention will consist on three identical meals coating 700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB intervention the breakfast will be omitted and the subject continue fasting until lunch. Then the participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at 19:00. The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with blood samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at the same time point the blood samples will be collected after 8:00 when the breakfast will be omitted. Expected results: The investigators expect that compared to NoB condition, in the YesB condition the postprandial response after lunch and dinner will be reduced for glucose and for FFA, while plasma insulin, C-peptide and GLP-1 postprandial response after lunch and dinner will be enhanced
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2014
CompletedFirst Posted
Study publicly available on registry
November 10, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJune 4, 2015
June 1, 2015
5 months
November 2, 2014
June 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of plasma glucose
Postprandial glycemia
5 weeks
Secondary Outcomes (3)
Measure of plasma Insulin
5 weeks
Measure of plasma GLP-1
5 weeks
Measure of free fatty acids (FFA)
5 weeks
Study Arms (2)
Skipping Breakfast (NoB)
EXPERIMENTALThe patients in No B will omit the breakfast and will continue the overnight fast until lunch. Will eat only lunch and dinner. In YesB will eat all three meals
Eating Breakfast (YesB):
ACTIVE COMPARATORThe patients in YesB will eat all three mealswill consume three meals: breakfast, lunch and dinner
Interventions
NoB: The patients will omit the breakfast, will continue the overnight fast until lunch, then will eat only lunch and dinner.
Eligibility Criteria
You may qualify if:
- T2D since \< 10 yrs, with HbA1c \> 7 % and BMI: 26-34 kg/m2.
- Only naïve or treated with oral antidiabetic drugs and with anti-hypertensive and lipid-lowering medication will be included.
- Those treated with insulin or GLP-1 analogs or having major liver, heart or kidney illnesses will be excluded.
You may not qualify if:
- Type 1 DM, secondary DM, gestational DM
- Patients using insulin, TZDs
- Patients using corticosteroid, herb medication or other medications affecting glucose tolerance
- Renal dysfunction (Cr \> 1.5mg/dL)
- Hepatic dysfunction (LFT \> x 3UNL)
- Anemia (Hg \> 10g/dL)
- Ischemic heart disease, congestive heart failure
- Severe diabetic complication (CRF, CVA, PDR, gastroparesis)
- Infectious disease
- Malignancy
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diabetes Unit E. Wolfson Medical center
Holon, Tel Aviv, 58100, Israel
Related Publications (1)
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(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PMID: 33512717DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Jakubowicz, MD
Diabetes Unit E. Wolfson Medical center Holon, Tel Aviv Israe
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
November 2, 2014
First Posted
November 10, 2014
Study Start
April 1, 2015
Primary Completion
September 1, 2015
Study Completion
November 1, 2015
Last Updated
June 4, 2015
Record last verified: 2015-06