Breakfast on Postprandial Hyperglycemia

Study Overview
=================
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.

Official Title
-----------------
Effect of Breakfast on Overall Postprandial Hyperglycemia in T2D

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Other: Breakfast eating (YesB)
* Other: Breakfast skipping (NoB)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: YesB<br>On YesB day the patients will consume breakfast , lunch and dinner | Other: Breakfast eating (YesB)<br>* On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00<br>Other: Breakfast skipping (NoB)<br>* On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00<br>|
| Experimental: NoB<br>On NoB Day The patient will consume only lunch and dinner | Other: Breakfast eating (YesB)<br>* On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00<br>Other: Breakfast skipping (NoB)<br>* On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Glucose | Postprandial Glucose will be measure after lunch and dinner | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial intact GLP-1 | Postprandial intact GLP-1 will be measure after lunch and dinner | 6 weeks | 
| Postprandial Insulin | Postprandial Insulin will be measure after lunch and dinner | 6 weeks | 
| Postprandial Glucagon | Postprandial Glucagon will be measure after lunch and dinner | 6 weeks | 
| Postprandial Free Fatty Acids | Postprandial Free Fatty Acids will be measure after lunch and dinner | 6 weeks |