Breakfast on Postprandial Hyperglycemia

Type 2 Diabetes Clinical Trial

— B-PPHG  

Official title:

Effect of Breakfast on Overall Postprandial Hyperglycemia in T2D

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02411682
• Other study ID #: HCCBI 057-2013-254
• Status: Active, not recruiting
• Phase: N/A
• First received: April 3, 2015
• Last updated: April 7, 2015
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Hospital de Clinicas Caracas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Ethics Committee
• Study type: Interventional

Clinical 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). Our aim was to explore the effect of skipping vs eating breakfast on PPHG after subsequent isocaloric (700kcal) lunch and dinner

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: April 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hyperglycemia
• Type 2 Diabetes

Intervention

Other:
• Breakfast eating (YesB)
On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00
• Breakfast skipping (NoB)
On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas Caracas	Tel Aviv University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial Glucose	Postprandial Glucose will be measure after lunch and dinner	6 weeks	No
Secondary	Postprandial intact GLP-1	Postprandial intact GLP-1 will be measure after lunch and dinner	6 weeks	No
Secondary	Postprandial Insulin	Postprandial Insulin will be measure after lunch and dinner	6 weeks	No
Secondary	Postprandial Glucagon	Postprandial Glucagon will be measure after lunch and dinner	6 weeks	No
Secondary	Postprandial Free Fatty Acids	Postprandial Free Fatty Acids will be measure after lunch and dinner	6 weeks	No