Clinical trial NCT02411682: Breakfast on Postprandial Hyperglycemia
Official title: Effect of Breakfast on Overall Postprandial Hyperglycemia in T2D
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Hospital de Clinicas Caracas
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2015-04-08
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postprandial Glucose
timeFrame: 6 weeks
Secondary outcomes:
measure: Postprandial intact GLP-1
timeFrame: 6 weeks
measure: Postprandial Insulin
timeFrame: 6 weeks
measure: Postprandial Glucagon
timeFrame: 6 weeks
measure: Postprandial Free Fatty Acids
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Clinicas Caracas
name: Daniela Jakubowicz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: E. Wolfson Medical Center. Israel
name: Daniela Jakubowicz, MD
role: PRINCIPAL_INVESTIGATOR
References: