Type 2 DiabetesOB-BNCT01571310
Effect of Breakfast or Omission of Breakfast in T2D
A study testing Omitted Breakfast and Breakfast in people with Type 2 Diabetes, run by Tel Aviv University at 2 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 30 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Omitted Breakfast and Breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner 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
Read the 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
- Conditions
- Type 2 Diabetes
- Being tested
- Omitted Breakfast, Breakfast
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omitted BreakfastOther
Also called Omission of 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
BreakfastOther
Also called Breakfast consupmtion
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:
| Study group | Role | What they receive |
|---|---|---|
| Omitted Breakfast | Experimental | 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 Receives: Other: Omitted Breakfast; Other: Breakfast |
| Breakfast | Active comparator | The patients in Breakfast day will consume breakfast at 8:00 and then lunch at 13;30 and dinner at 19:00 Receives: Other: Omitted Breakfast; Other: Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glucose Response
Postprandial Glucose response will be measure after lunch and dinner
Measured: 12 weeks
Secondary outcomes (4)
Postprandial Insulin Response
Postprandial Insulin response will be measure after lunch and dinner
Measured: 12 weeks
Postprandial intact-GLP-1 Response
Postprandial intact-GLP-1 response will be measure after lunch and dinner
Measured: 12 weeks
Postprandial Glucagon Response
Postprandial Glucagon response will be measure after lunch and dinner
Measured: 12 weeks
Postprandial Free Fatty Acids Response
Postprandial Free Fatty Acids response will be measure after lunch and dinner
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas Caracas
- Responsible party
- Principal investigator, Daniela Jakubowicz, Tel Aviv University
- Investigators
- Julio Wainstein, MD, Principal investigator, Head of Diabetes Unit E. Wolfson Medical Center IsraelDaniela Jakubowicz, MD, Principal investigator, Hospital de Clinicas Caracas, Venezuela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571310
- Sponsor's protocol ID
- HCCCBI 017-2007-112
- Acronym
- OB-B
- Status last verified
- Oct 2017
- First submitted
- 30 Mar 2012
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
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(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
PubMed 33512717
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner in T2D
- ClinicalTrials.gov ID
- NCT01571310
- Acronym / sponsor ID
- OB-B / HCCCBI 017-2007-112
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Hospital de Clinicas Caracas
- Study start
- Jul 2012 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omitted Breakfast | Experimental | Other: Omitted Breakfast, Other: BreakfastExperimental: 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 |
| Breakfast | Active comparator | Other: Omitted Breakfast, Other: BreakfastThe patients in Breakfast day will consume breakfast at 8:00 and then lunch at 13;30 and dinner at 19:00 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Type 2 diabetics for < 10yr
- HbA1C: 7-9 %
- BMI: 22 to 35 kg/m2)
- Age: ≥30 and ≤70 years of age
- Habitually eat breakfast
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omitted BreakfastAlso: Omission of BreakfastExperimental: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 | Breakfast, Omitted Breakfast |
| BreakfastAlso: Breakfast consupmtionIn 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 | Breakfast, Omitted Breakfast |
Primary outcome
Postprandial Glucose Response
Time frame: 12 weeks
Postprandial Glucose response will be measure after lunch and dinner
4 secondary outcomes
Postprandial Insulin Response
Time frame: 12 weeks
Postprandial intact-GLP-1 Response
Time frame: 12 weeks
Postprandial Glucagon Response
Time frame: 12 weeks
Postprandial Free Fatty Acids Response
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Derived from this study: PubMed 33512717Allaf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Wainstein, MD principal investigator
Head of Diabetes Unit E. Wolfson Medical Center Israel
Daniela Jakubowicz, MD principal investigator
Hospital de Clinicas Caracas, Venezuela
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omitted Breakfast and Breakfast in people with Type 2 Diabetes, run by Tel Aviv University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel, Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Glucose Response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.