Type 2 DiabetesB-PPHGNCT02411682
Breakfast on Postprandial Hyperglycemia
A study testing Breakfast eating (YesB) and Breakfast skipping (NoB) in people with Type 2 Diabetes, run by Hospital de Clinicas Caracas.
Trial summary
Reduction of postprandial hyperglycemia (PPHG) is a major target in the treatment of type 2 diabetes (T2D). Skipping breakfast has been consistently associated with higher HbA1c and overall PPHG in subjects with type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Breakfast eating (YesB) and Breakfast skipping (NoB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Apr 2015
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI: 26-34 kg/m2.
- HbA1c > 7 %
- T2D since < 10 yrs,
- . Only non treated or treated with oral antidiabetic drugs
- Those treated with insulin or GLP-1 analogs will be excluded.
Who cannot join
- Type 1 diabetes
- Serum creatinine level > 1.5 mg/dl
- Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications,such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or anemia (Hg > 10g/dL) or underwent bariatric surgery.
- Abnormal liver function tests
- Participating in dietary program or using of weight-loss medications
- History (within one year) of illicit drug abuse or alcoholism.
- Use of psychotropic or anoretic medication during the month immediately prior to study onset
About this study
Official title: Effect of Breakfast on Overall Postprandial Hyperglycemia in T2D
Reduction of postprandial hyperglycemia (PPHG) is a major target in the treatment of type 2 diabetes (T2D). Skipping breakfast has been consistently associated with higher HbA1c and overall PPHG in subjects with type 2 diabetes (T2D). Our aim was to explore the effect of skipping vs eating breakfast on PPHG after subsequent isocaloric (700kcal) lunch and dinner
Read the detailed description
In type 2 diabetic individuals the omission of breakfast is associated with significant increase in HbA1C and all-day postprandial hyperglycemia even without overeating in the evening. In contrast, high-energy breakfast and low-energy dinner result in a significant reduction of all-day postprandial glycaemia Similarly, 3 months of high-energy breakfast led to a 5% reduction in HbA1C levels in type 2 diabetes participants Despite the growing evidence showing the beneficial effects of breakfast consumption on overall postprandial hyperglycemia and HbA1C levels, very little is known regarding the relationship between breakfast skipping and all-day glycemic excursions in type 2 diabetes patients. Therefore, to test whether breakfast skipping influences metabolic responses to the following meals in type 2 diabetes patients during the same day, we explored the postprandial glycemic response to identical lunch and dinner meal tests with or without breakfast.
- Conditions
- Type 2 Diabetes
- Being tested
- Breakfast eating (YesB), Breakfast skipping (NoB)
- 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.
Breakfast eating (YesB)Other
On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00
Breakfast skipping (NoB)Other
On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00
| Study group | Role | What they receive |
|---|---|---|
| YesB | Active comparator | On YesB day the patients will consume breakfast , lunch and dinner Receives: Other: Breakfast eating (YesB); Other: Breakfast skipping (NoB) |
| NoB | Experimental | On NoB Day The patient will consume only lunch and dinner Receives: Other: Breakfast eating (YesB); Other: Breakfast skipping (NoB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glucose
Postprandial Glucose will be measure after lunch and dinner
Measured: 6 weeks
Secondary outcomes (4)
Postprandial intact GLP-1
Postprandial intact GLP-1 will be measure after lunch and dinner
Measured: 6 weeks
Postprandial Insulin
Postprandial Insulin will be measure after lunch and dinner
Measured: 6 weeks
Postprandial Glucagon
Postprandial Glucagon will be measure after lunch and dinner
Measured: 6 weeks
Postprandial Free Fatty Acids
Postprandial Free Fatty Acids will be measure after lunch and dinner
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionJul 2014
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas Caracas
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Daniela Jakubowicz, MD, Hospital de Clinicas Caracas
- Investigators
- Daniela Jakubowicz, MD, Principal investigator, Hospital de Clinicas CaracasDaniela Jakubowicz, MD, Principal investigator, E. Wolfson Medical Center. Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411682
- Sponsor's protocol ID
- HCCBI 057-2013-254
- Acronym
- B-PPHG
- Status last verified
- Apr 2015
- First submitted
- 3 Apr 2015
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breakfast on Overall Postprandial Hyperglycemia in T2D
- ClinicalTrials.gov ID
- NCT02411682
- Acronym / sponsor ID
- B-PPHG / HCCBI 057-2013-254
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hospital de Clinicas CaracasUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- May 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Apr 2015 (estimated)
- First posted
- 8 Apr 2015 (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.
Reduction of postprandial hyperglycemia (PPHG) is a major target in the treatment of type 2 diabetes (T2D). Skipping breakfast has been consistently associated with higher HbA1c and overall PPHG in subjects with type 2 diabetes (T2D). Our aim was to explore the effect of skipping vs eating breakfast on PPHG after subsequent isocaloric (700kcal) lunch and dinner
Detailed description
In type 2 diabetic individuals the omission of breakfast is associated with significant increase in HbA1C and all-day postprandial hyperglycemia even without overeating in the evening. In contrast, high-energy breakfast and low-energy dinner result in a significant reduction of all-day postprandial glycaemia Similarly, 3 months of high-energy breakfast led to a 5% reduction in HbA1C levels in type 2 diabetes participants Despite the growing evidence showing the beneficial effects of breakfast consumption on overall postprandial hyperglycemia and HbA1C levels, very little is known regarding the relationship between breakfast skipping and all-day glycemic excursions in type 2 diabetes patients. Therefore, to test whether breakfast skipping influences metabolic responses to the following meals in type 2 diabetes patients during the same day, we explored the postprandial glycemic response to identical lunch and dinner meal tests with or without breakfast.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YesB | Active comparator | Other: Breakfast eating (YesB), Other: Breakfast skipping (NoB)On YesB day the patients will consume breakfast , lunch and dinner |
| NoB | Experimental | Other: Breakfast eating (YesB), Other: Breakfast skipping (NoB)On NoB Day The patient will consume only lunch and dinner |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI: 26-34 kg/m2.
- HbA1c > 7 %
- T2D since < 10 yrs,
- . Only non treated or treated with oral antidiabetic drugs
- Those treated with insulin or GLP-1 analogs will be excluded.
Key exclusion criteria (7 listed)
- Type 1 diabetes
- Serum creatinine level > 1.5 mg/dl
- Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications,such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or anemia (Hg > 10g/dL) or underwent bariatric surgery.
- Abnormal liver function tests
- Participating in dietary program or using of weight-loss medications
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 |
|---|---|---|
| Breakfast eating (YesB)On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00 | Other | NoB, YesB |
| Breakfast skipping (NoB)On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00 | Other | NoB, YesB |
Primary outcome
Postprandial Glucose
Time frame: 6 weeks
Postprandial Glucose will be measure after lunch and dinner
4 secondary outcomes
Postprandial intact GLP-1
Time frame: 6 weeks
Postprandial Insulin
Time frame: 6 weeks
Postprandial Glucagon
Time frame: 6 weeks
Postprandial Free Fatty Acids
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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.
Daniela Jakubowicz, MD principal investigator
Hospital de Clinicas Caracas
Daniela Jakubowicz, MD principal investigator
E. Wolfson Medical Center. Israel
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast eating (YesB) and Breakfast skipping (NoB) in people with Type 2 Diabetes, run by Hospital de Clinicas Caracas.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.