Type 2 DiabetesNCT02180646
Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes
A study testing High protein breakfast and High carb breakfast in people with Type 2 Diabetes, run by University of Missouri-Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- High protein breakfast and High carb breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%
Who cannot join
- insulin
- β-blockers
- GLP-1 agonists (e.g. exenatide)
- dipeptidyl peptidase (DPP) inhibitors
- weight loss
- using weight-loss medications
- pregnant or lactating
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- High protein breakfast, High carb breakfast
- Keywords
- GLP-1, GIP, second meal phenomena, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High protein breakfastOther
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
High carb breakfastOther
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
| Study group | Role | What they receive |
|---|---|---|
| High Carb then High Protein Breakfast | Active comparator | 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). Receives: Other: High protein breakfast; Other: High carb breakfast |
| High Protein then High Carb Breakfast | Active comparator | 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) Receives: Other: High protein breakfast; Other: High carb breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose Level Post-meal (AUC [0-4])
AUC for 4 hr after breakfast and after lunch
Measured: 0-240 and 240-480
Secondary outcomes (1)
Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)
AUC for 4 hr after breakfast and after lunch
Measured: 0-240 and 240-480
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- American Egg Board
- Responsible party
- Principal investigator, Jill Kanaley, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180646
- Sponsor's protocol ID
- b2d2-01
- Status last verified
- Oct 2019
- First submitted
- 30 Jun 2014
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25733459
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a High Protein Breakfast on Glycemic Control, Insulin Sensitivity, and Beta Cell Function in Individuals With Type 2 Diabetes (T2D)
- ClinicalTrials.gov ID
- NCT02180646
- Acronym / sponsor ID
- b2d2-01
- Conditions
- Type 2 Diabetes
- Keywords
- GLP-1, GIP, second meal phenomena, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- American Egg Board
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Jul 2014 (estimated)
- Results
- Posted 18 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Carb then High Protein Breakfast | Active comparator | Other: High protein breakfast, Other: High carb breakfastA 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). |
| High Protein then High Carb Breakfast | Active comparator | Other: High protein breakfast, Other: High carb breakfastA 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) |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (7 listed)
- insulin
- β-blockers
- GLP-1 agonists (e.g. exenatide)
- dipeptidyl peptidase (DPP) inhibitors
- weight loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High protein breakfasta high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) | Other | High Carb then High Protein Breakfast, High Protein then High Carb Breakfast |
| High carb breakfasta high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) | Other | High Carb then High Protein Breakfast, High Protein then High Carb Breakfast |
Primary outcome
Plasma Glucose Level Post-meal (AUC [0-4])
Time frame: 0-240 and 240-480
AUC for 4 hr after breakfast and after lunch
1 secondary outcome
Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)
Time frame: 0-240 and 240-480
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25733459Park 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High protein breakfast and High carb breakfast in people with Type 2 Diabetes, run by University of Missouri-Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Glucose Level Post-meal (AUC [0-4]) (time frame: 0-240 and 240-480). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.