Breakfast on Postprandial Hyperglycemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-04-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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YesB

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

Group Type ACTIVE_COMPARATOR

Breakfast eating (YesB)

Intervention Type OTHER

On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00

Breakfast skipping (NoB)

Intervention Type OTHER

On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00

NoB

On NoB Day The patient will consume only lunch and dinner

Group Type EXPERIMENTAL

Breakfast eating (YesB)

Intervention Type OTHER

On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00

Breakfast skipping (NoB)

Intervention Type OTHER

On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00

Interventions

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Breakfast eating (YesB)

On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00

Intervention Type OTHER

Breakfast skipping (NoB)

On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No