Type 2 Diabetes
Conditions
Keywords
GLP-1, GIP, second meal phenomena, type 2 diabetes
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.
Interventions
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
OTHERHigh carb breakfast
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
Sponsors
American Egg Board
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Glucose Level Post-meal (AUC [0-4]) | 0-240 and 240-480 | AUC for 4 hr after breakfast and after lunch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC) | 0-240 and 240-480 | AUC for 4 hr after breakfast and after lunch |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-meal Insulin Level (AUC [0-4]) | 0-240 and 240-480 | AUC for 4 hr after breakfast and after lunch |
| Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC ) | 0-240 and 240-480 | AUC for 4 hr after breakfast and after lunch |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Carb Then High Protein Breakfast A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) for 7 days, followed by 7-day washout, followed by a high protein breakfast for 7 days | 6 |
| High Protein Then High Carb Breakfast A high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) for 7 days, followed by a 7-day washout, followed by a high carbohydrate breakfast for 7 days | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | High Carb Then High Protein Breakfast | High Protein Then High Carb Breakfast | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Plasma Glucose Level Post-meal (AUC [0-4])
AUC for 4 hr after breakfast and after lunch
Time frame: 0-240 and 240-480
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Protein Breakfast | Plasma Glucose Level Post-meal (AUC [0-4]) | 28426 min*pg/ml | Standard Error 1660 |
| High Carbohydrate Breakfast | Plasma Glucose Level Post-meal (AUC [0-4]) | 33911 min*pg/ml | Standard Error 2590 |
Secondary
Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)
AUC for 4 hr after breakfast and after lunch
Time frame: 0-240 and 240-480
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Protein Breakfast | Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC) | 15156 min*pg/ml | Standard Error 3100 |
| High Carbohydrate Breakfast | Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC) | 14620 min*pg/ml | Standard Error 1814 |
Other Pre-specified
Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC )
AUC for 4 hr after breakfast and after lunch
Time frame: 0-240 and 240-480
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Protein Breakfast | Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC ) | 14 ng/ml x min for 4 h | Standard Error 3.1 |
| High Carbohydrate Breakfast | Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC ) | 11.5 ng/ml x min for 4 h | Standard Error 2 |
Other Pre-specified
Post-meal Insulin Level (AUC [0-4])
AUC for 4 hr after breakfast and after lunch
Time frame: 0-240 and 240-480
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Protein Breakfast | Post-meal Insulin Level (AUC [0-4]) | 428869 min*pg/ml | Standard Error 55831 |
| High Carbohydrate Breakfast | Post-meal Insulin Level (AUC [0-4]) | 474236 min*pg/ml | Standard Error 53518 |