Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments breakfast eating (yesb), breakfast skipping (nob)
Sponsor Hospital de Clinicas Caracas
Collaborator Tel Aviv University
Start date May 2014
End date July 2014
Trial size 28 participants
Trial identifier NCT02411682, HCCBI 057-2013-254

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
On YesB day the patients will consume breakfast , lunch and dinner
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
(Experimental)
On NoB Day The patient will consume only lunch and dinner
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

Primary Outcomes

Measure
Postprandial Glucose
time frame: 6 weeks

Secondary Outcomes

Measure
Postprandial intact GLP-1
time frame: 6 weeks
Postprandial Insulin
time frame: 6 weeks
Postprandial Glucagon
time frame: 6 weeks
Postprandial Free Fatty Acids
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

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

Additional Information

Official title Effect of Breakfast on Overall Postprandial Hyperglycemia in T2D
Principal investigator Daniela Jakubowicz, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Hospital de Clinicas Caracas.