Breakfast on Postprandial Hyperglycemia

Not Applicable

• Conditions: Type 2 Diabetes

• Registration Number: NCT02411682
• Lead Sponsor: Hospital de Clinicas Caracas

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.

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-07
• Status Verified: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-07
• Last Update Submitted: 2015-04-07
• Study First Posted: 2015-04-08
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Postprandial Glucose	6 weeks	Postprandial Glucose will be measure after lunch and dinner

Secondary Outcome Measures

Name	Time	Method
Postprandial Insulin	6 weeks	Postprandial Insulin will be measure after lunch and dinner
Postprandial intact GLP-1	6 weeks	Postprandial intact GLP-1 will be measure after lunch and dinner
Postprandial Free Fatty Acids	6 weeks	Postprandial Free Fatty Acids will be measure after lunch and dinner
Postprandial Glucagon	6 weeks	Postprandial Glucagon will be measure after lunch and dinner