Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Eating vs Skipping Breakfast on Postprandial Hyperglycemia After Subsequent Isocaloric Lunch and Dinner in Type 2 Diabetic Patients
Brief Summary: Background: Skipping breakfast and/or overeating at evening, has been associated in type 2 diabetic (T2D) individuals, with higher BMI, visceral adiposity, hyperlipidemia, increased overall postprandial glycemia (PPHG) and higher HbA1c. The absence of breakfast is also associated with increased plasma free fatty acids (FFA) along the morning until lunch. High plasma FFA in turn are triggering factor of insulin resistance, by inhibiting insulin mediated glucose uptake in obese and T2D subjects The investigators therefore hypothesize that compared to eating breakfast the prolonged overnight fasting caused by the breakfast omission will result in increased postprandial glycemic response after subsequent isocaloric lunch and dinner in T2D individuals.

Objectives: With this aim will study T2D patients in randomized crossover design to consume in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition (YesB) or omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner with the same caloric content.

Methods and Study Design: The YesB intervention will consist on three identical meals coating 700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB intervention the breakfast will be omitted and the subject continue fasting until lunch. Then the participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at 19:00. The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with blood samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at the same time point the blood samples will be collected after 8:00 when the breakfast will be omitted.

Expected results: The investigators expect that compared to NoB condition, in the YesB condition the postprandial response after lunch and dinner will be reduced for glucose and for FFA, while plasma insulin, C-peptide and GLP-1 postprandial response after lunch and dinner will be enhanced


Options:
A: Arm Label: Skipping Breakfast (NoB); Type: EXPERIMENTAL; Interventions: Other: Skipping Breakfast | Arm Label: Eating Breakfast (YesB):; Type: ACTIVE_COMPARATOR; Interventions: Other: Eating Breakfast | Intervention Type: OTHER; Name: Skipping Breakfast; Assigned to Arm(s): Skipping Breakfast (NoB) | Intervention Type: OTHER; Name: Eating Breakfast; Assigned to Arm(s): Eating Breakfast (YesB):
B: Arm Label: Intermittent Energy Restriction; Type: EXPERIMENTAL; Interventions: Behavioral: Intermittent Energy Restriction | Arm Label: Continuous Energy Restriction; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Continuous Energy Restriction | Intervention Type: BEHAVIORAL; Name: Intermittent Energy Restriction; Assigned to Arm(s): Intermittent Energy Restriction | Intervention Type: BEHAVIORAL; Name: Continuous Energy Restriction; Assigned to Arm(s): Continuous Energy Restriction
C: Arm Label: Alternate day fasting; Type: EXPERIMENTAL; Interventions: Other: Alternate day fasting | Intervention Type: OTHER; Name: Alternate day fasting; Assigned to Arm(s): Alternate day fasting
D: Arm Label: Alternate day fasting (ADF); Type: EXPERIMENTAL; Interventions: Other: Alternate day fasting | Arm Label: Calorie restriction (CR); Type: EXPERIMENTAL; Interventions: Other: Calorie restriction | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Control diet | Intervention Type: OTHER; Name: Alternate day fasting; Assigned to Arm(s): Alternate day fasting (ADF) | Intervention Type: OTHER; Name: Calorie restriction; Assigned to Arm(s): Calorie restriction (CR) | Intervention Type: OTHER; Name: Control diet; Assigned to Arm(s): Control

Answer: A