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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02180646
Recruitment Status : Completed
First Posted : July 3, 2014
Results First Posted : January 18, 2017
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Jill Kanaley, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: High protein breakfast Other: High carb breakfast Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 Start Date : December 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: High Carb then High Protein Breakfast
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).
Other: High protein breakfast
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)

Other: High carb breakfast
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)

Active Comparator: High Protein then High Carb Breakfast
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)
Other: High protein breakfast
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)

Other: High carb breakfast
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)




Primary Outcome Measures :
  1. Plasma Glucose Level Post-meal (AUC [0-4]) [ Time Frame: 0-240 and 240-480 ]
    AUC for 4 hr after breakfast and after lunch


Secondary Outcome Measures :
  1. Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC) [ Time Frame: 0-240 and 240-480 ]
    AUC for 4 hr after breakfast and after lunch


Other Outcome Measures:
  1. Post-meal Insulin Level (AUC [0-4]) [ Time Frame: 0-240 and 240-480 ]
    AUC for 4 hr after breakfast and after lunch

  2. Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC ) [ Time Frame: 0-240 and 240-480 ]
    AUC for 4 hr after breakfast and after lunch



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jill Kanaley, professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02180646    
Other Study ID Numbers: b2d2-01
First Posted: July 3, 2014    Key Record Dates
Results First Posted: January 18, 2017
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jill Kanaley, University of Missouri-Columbia:
GLP-1
GIP
second meal phenomena
type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases