Breakfast on Postprandial Hyperglycemia (B-PPHG)

Hospital de Clinicas Caracas

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Other: Breakfast eating (YesB); Other: Breakfast skipping (NoB)

Study type: Interventional

Funder types: Other

Identifiers

NCT02411682

HCCBI 057-2013-254

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

YesB

Active Comparator group

Description:

On YesB day the patients will consume breakfast , lunch and dinner

Treatment:

Other: Breakfast skipping (NoB)

Other: Breakfast eating (YesB)

NoB

Experimental group

Description:

On NoB Day The patient will consume only lunch and dinner

Treatment:

Other: Breakfast skipping (NoB)

Other: Breakfast eating (YesB)