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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
Hospital de Clinicas Caracas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 3, 2015
    Last Updated
    April 7, 2015
    Sponsor
    Hospital de Clinicas Caracas
    Collaborators
    Tel Aviv University
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    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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