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OpenTrials
Completed

NCT Number: NCT02180646

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Protein Breakfast

Other

a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)

High carb breakfast

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • American Egg Board

Registry information

Official study title

Effect of a High Protein Breakfast on Glycemic Control, Insulin Sensitivity, and Beta Cell Function in Individuals With Type 2 Diabetes (T2D)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 3, 2014
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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