Breakfast on Postprandial Hyperglycemia (B-PPHG)
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Breakfast eating (YesB)
Breakfast skipping (NoB)
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 2 Diabetes
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
YesB
NoB
Arm Description
On YesB day the patients will consume breakfast , lunch and dinner
On NoB Day The patient will consume only lunch and dinner
Outcomes
Primary Outcome Measures
Postprandial Glucose
Postprandial Glucose will be measure after lunch and dinner
Secondary Outcome Measures
Postprandial intact GLP-1
Postprandial intact GLP-1 will be measure after lunch and dinner
Postprandial Insulin
Postprandial Insulin will be measure after lunch and dinner
Postprandial Glucagon
Postprandial Glucagon will be measure after lunch and dinner
Postprandial Free Fatty Acids
Postprandial Free Fatty Acids will be measure after lunch and dinner
Full Information
NCT ID
NCT02411682
First Posted
April 3, 2015
Last Updated
April 7, 2015
Sponsor
Hospital de Clinicas Caracas
Collaborators
Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT02411682
Brief Title
Breakfast on Postprandial Hyperglycemia
Acronym
B-PPHG
Official Title
Effect of Breakfast on Overall Postprandial Hyperglycemia in T2D
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas Caracas
Collaborators
Tel Aviv University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
YesB
Arm Type
Active Comparator
Arm Description
On YesB day the patients will consume breakfast , lunch and dinner
Arm Title
NoB
Arm Type
Experimental
Arm Description
On NoB Day The patient will consume only lunch and dinner
Intervention Type
Other
Intervention Name(s)
Breakfast eating (YesB)
Intervention Description
On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00
Intervention Type
Other
Intervention Name(s)
Breakfast skipping (NoB)
Intervention Description
On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00
Primary Outcome Measure Information:
Title
Postprandial Glucose
Description
Postprandial Glucose will be measure after lunch and dinner
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Postprandial intact GLP-1
Description
Postprandial intact GLP-1 will be measure after lunch and dinner
Time Frame
6 weeks
Title
Postprandial Insulin
Description
Postprandial Insulin will be measure after lunch and dinner
Time Frame
6 weeks
Title
Postprandial Glucagon
Description
Postprandial Glucagon will be measure after lunch and dinner
Time Frame
6 weeks
Title
Postprandial Free Fatty Acids
Description
Postprandial Free Fatty Acids will be measure after lunch and dinner
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Jakubowicz, MD
Organizational Affiliation
Hospital de Clinicas Caracas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniela Jakubowicz, MD
Organizational Affiliation
E. Wolfson Medical Center. Israel
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Breakfast on Postprandial Hyperglycemia
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