Breakfast on Postprandial Hyperglycemia
B-PPHG
Effect of Breakfast on Overall Postprandial Hyperglycemia in T2D
1 other identifier
interventional
28
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started May 2014
Shorter than P25 for not_applicable type-2-diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 3, 2015
CompletedFirst Posted
Study publicly available on registry
April 8, 2015
CompletedApril 8, 2015
April 1, 2015
2 months
April 3, 2015
April 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Postprandial Glucose
Postprandial Glucose will be measure after lunch and dinner
6 weeks
Secondary Outcomes (4)
Postprandial intact GLP-1
6 weeks
Postprandial Insulin
6 weeks
Postprandial Glucagon
6 weeks
Postprandial Free Fatty Acids
6 weeks
Study Arms (2)
YesB
ACTIVE COMPARATOROn YesB day the patients will consume breakfast , lunch and dinner
NoB
EXPERIMENTALOn NoB Day The patient will consume only lunch and dinner
Interventions
On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00
On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital de Clinicas Caracaslead
- Tel Aviv Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Jakubowicz, MD
Hospital de Clinicas Caracas
- PRINCIPAL INVESTIGATOR
Daniela Jakubowicz, MD
E. Wolfson Medical Center. Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Daniela Jakubowicz MD
Study Record Dates
First Submitted
April 3, 2015
First Posted
April 8, 2015
Study Start
May 1, 2014
Primary Completion
July 1, 2014
Study Completion
April 1, 2015
Last Updated
April 8, 2015
Record last verified: 2015-04