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Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High protein breakfast
High carb breakfast
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes focused on measuring GLP-1, GIP, second meal phenomena, type 2 diabetes

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 21-55 y of age
  • body mass index (BMI) between 30-40 kg/m2
  • weight stable for the prior 6 months
  • non-smokers
  • minimal alcohol consumption (< 2 drinks per day)
  • type 2 diabetic (diagnosed ≥ 2 y)
  • a fasting glucose level above 120 mg/dL
  • HbA1c between 6.5-9.0%

Exclusion Criteria:

  • insulin
  • β-blockers
  • GLP-1 agonists (e.g. exenatide)
  • dipeptidyl peptidase (DPP) inhibitors
  • weight loss
  • using weight-loss medications
  • pregnant or lactating

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    High Carb then High Protein Breakfast

    High Protein then High Carb Breakfast

    Arm Description

    A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) followed by a 7-day washout period, and then 7 days of eating a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat).

    A high protein breakfast - 500 kcal followed by a 7-day washout period, and then 7 days of eating a high carbohydrate breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)

    Outcomes

    Primary Outcome Measures

    Plasma Glucose Level Post-meal (AUC [0-4])
    AUC for 4 hr after breakfast and after lunch

    Secondary Outcome Measures

    Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)
    AUC for 4 hr after breakfast and after lunch

    Full Information

    First Posted
    June 30, 2014
    Last Updated
    October 1, 2019
    Sponsor
    University of Missouri-Columbia
    Collaborators
    American Egg Board
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02180646
    Brief Title
    Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes
    Official Title
    Effect of a High Protein Breakfast on Glycemic Control, Insulin Sensitivity, and Beta Cell Function in Individuals With Type 2 Diabetes (T2D)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Missouri-Columbia
    Collaborators
    American Egg Board

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study examined the effect of a high protein or high carbohydrate breakfast on the glucose and insulin response following the breakfast meal, as well as the subsequent response following the lunch meal.
    Detailed Description
    Twelve habitual breakfast consumers with type 2 diabetes (T2D) were recruited for the study. They completed two, 7-day conditions in random order with a minimum of a 7-day washout period between study days. They consumed either a high protein (PRO) or high carbohydrate (CHO) breakfast for 6 days of acclimatization, and on the seventh day, they reported to the lab at 0700 hours following a ~12 hour overnight fast and underwent forearm catheterization before a baseline blood draw. The participants consumed the respective breakfast at ~0730 hours. Four hours post-breakfast, subjects consumed a standard lunch meal. Blood samples were taken continuously throughout the 8-hour test day.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes
    Keywords
    GLP-1, GIP, second meal phenomena, type 2 diabetes

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    High Carb then High Protein Breakfast
    Arm Type
    Active Comparator
    Arm Description
    A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) followed by a 7-day washout period, and then 7 days of eating a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat).
    Arm Title
    High Protein then High Carb Breakfast
    Arm Type
    Active Comparator
    Arm Description
    A high protein breakfast - 500 kcal followed by a 7-day washout period, and then 7 days of eating a high carbohydrate breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
    Intervention Type
    Other
    Intervention Name(s)
    High protein breakfast
    Intervention Description
    a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
    Intervention Type
    Other
    Intervention Name(s)
    High carb breakfast
    Intervention Description
    a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
    Primary Outcome Measure Information:
    Title
    Plasma Glucose Level Post-meal (AUC [0-4])
    Description
    AUC for 4 hr after breakfast and after lunch
    Time Frame
    0-240 and 240-480
    Secondary Outcome Measure Information:
    Title
    Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)
    Description
    AUC for 4 hr after breakfast and after lunch
    Time Frame
    0-240 and 240-480
    Other Pre-specified Outcome Measures:
    Title
    Post-meal Insulin Level (AUC [0-4])
    Description
    AUC for 4 hr after breakfast and after lunch
    Time Frame
    0-240 and 240-480
    Title
    Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC )
    Description
    AUC for 4 hr after breakfast and after lunch
    Time Frame
    0-240 and 240-480

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 21-55 y of age body mass index (BMI) between 30-40 kg/m2 weight stable for the prior 6 months non-smokers minimal alcohol consumption (< 2 drinks per day) type 2 diabetic (diagnosed ≥ 2 y) a fasting glucose level above 120 mg/dL HbA1c between 6.5-9.0% Exclusion Criteria: insulin β-blockers GLP-1 agonists (e.g. exenatide) dipeptidyl peptidase (DPP) inhibitors weight loss using weight-loss medications pregnant or lactating

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    25733459
    Citation
    Park YM, Heden TD, Liu Y, Nyhoff LM, Thyfault JP, Leidy HJ, Kanaley JA. A high-protein breakfast induces greater insulin and glucose-dependent insulinotropic peptide responses to a subsequent lunch meal in individuals with type 2 diabetes. J Nutr. 2015 Mar;145(3):452-8. doi: 10.3945/jn.114.202549. Epub 2014 Dec 24.
    Results Reference
    derived

    Learn more about this trial

    Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes

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