- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180646
Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes
October 1, 2019 updated by: Jill Kanaley, University of Missouri-Columbia
Effect of a High Protein Breakfast on Glycemic Control, Insulin Sensitivity, and Beta Cell Function in Individuals With Type 2 Diabetes (T2D)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
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)
|
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Glucose Level Post-meal (AUC [0-4])
Time Frame: 0-240 and 240-480
|
AUC for 4 hr after breakfast and after lunch
|
0-240 and 240-480
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0-240 and 240-480
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-meal Insulin Level (AUC [0-4])
Time Frame: 0-240 and 240-480
|
AUC for 4 hr after breakfast and after lunch
|
0-240 and 240-480
|
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
|
0-240 and 240-480
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
June 30, 2014
First Submitted That Met QC Criteria
July 2, 2014
First Posted (Estimate)
July 3, 2014
Study Record Updates
Last Update Posted (Actual)
October 3, 2019
Last Update Submitted That Met QC Criteria
October 1, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- b2d2-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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