Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F3Z-EW-IOPT | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Study is looking at whether high blood glucose levels after a meal affect arterial stiffness more or less than low blood glucose levels, and whether certain cardiovascular markers influence the outcome of this.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2DM, albuminuria but normal kidney function | Experimental |
| |
| Healthy participants | No Intervention | ||
| T2DM, normal urinary albumin excretion rate (UAER) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lispro | Drug | Dosage based on participants with type 2 diabetes mellitus (T2DM) normal morning insulin dose and energy content of participant's normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast | The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant. | 30 mins (pre-breakfast) |
| Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast | The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant. | 60 mins (post-breakfast) |
| Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast | The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant. | 120 mins (post-breakfast) |
| Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast | The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant. | 180 mins (post-breakfast) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pulse Wave Amplitude (PWA) | The PWA measured systemic arterial stiffness (augmentation index). PWA was reported as a percentage of systolic peak and calculated as the difference between second and first systolic peak in an ascending aortic pulse pressure waveform divided by the first systolic peak then multiplied by 100. The change in PWA from baseline [30-minute (min) pre-breakfast] is reported. |
Not provided
Inclusion Criteria:
Healthy participants are eligible to be included in the study only if they meet all of the following criteria:
Exclusion Criteria:
Participants/healthy participants will be excluded from the study if they meet any of the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Helsinki | 00014 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31119456 | Derived | Gordin D, Saraheimo M, Tuomikangas J, Soro-Paavonen A, Forsblom C, Paavonen K, Steckel-Hamann B, Harjutsalo V, Nicolaou L, Pavo I, Koivisto V, Groop PH. Insulin exposure mitigates the increase of arterial stiffness in patients with type 2 diabetes and albuminuria: an exploratory analysis. Acta Diabetol. 2019 Nov;56(11):1169-1175. doi: 10.1007/s00592-019-01351-4. Epub 2019 May 22. | |
| 26731258 |
Not provided
Not provided
Participants with type 2 diabetes mellitus (T2DM) were randomized to either a high to low blood glucose sequence or a low to high blood glucose sequence dependent upon whether they received insulin lispro or not in the first study period. Participants were stratified into treatment arms based on their urinary albumin excretion rate (UAER).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants | Healthy participants with normal glucose tolerance and normal UAER did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection. |
| FG001 | T2DM With Albuminuria, High to Low | T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. |
| FG002 | T2DM With Albuminuria, Low to High | T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. |
| FG003 | T2DM With Normal UAER, High to Low | T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. |
| FG004 | T2DM With Normal UAER, Low to High | T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Study Period |
|
| ||||||||||||||||||||||||
| Second Study Period |
|
All enrolled participants, with the exception of 1 healthy participant who completed the study but was later excluded from analyses due to major protocol violation.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Participants | Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast | The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant. | Randomized T2DM participants who were scheduled to receive study drug and had a baseline PWV measurement at the specified time point and no major protocol deviation. | Posted | Least Squares Mean | 95% Confidence Interval | meters per second (m/s) | 30 mins (pre-breakfast) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Participants | Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast |
The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant. |
| 240 mins (post-breakfast) |
| 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) |
| Change in Peripheral Artery Tonometry (PAT) | The PAT device is a pneumatic plethysmograph that applies uniform pressure to the surface of each finger tip and measures digital pulse amplitude. The PAT was reported as a percentage of pulse amplitude and expressed as the ratio of post deflation to baseline pulse amplitude in hyperemic finger divided by the same ratio in the contralateral finger that served as a control. The change in PAT from baseline [30-minute (min) pre-breakfast] is reported. | 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast) |
| Change in QT Interval on Electrocardiogram (ECG) | QT interval is a measure of time from the beginning of the QRS complex to the end of the T wave on an ECG during which contraction of the ventricles occurs. Changes in QT interval from baseline [30-minute (min) pre-breakfast] are reported. | 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) |
| Change in Blood Glucose (BG) | Changes in BG from the baseline [30-minute (min) pre-breakfast] are reported. | 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast) |
| Change in Postprandial Pulse Wave Velocity (PWV) | The PWV measured arterial stiffness in the aortic and brachial arteries of healthy participants and T2DM participants. Changes in PWV from baseline [30-minute (min) pre-breakfast] are reported. | 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) |
| Finland |
| Derived |
| Gordin D, Saraheimo M, Tuomikangas J, Soro-Paavonen A, Forsblom C, Paavonen K, Steckel-Hamann B, Vandenhende F, Nicolaou L, Pavo I, Koivisto V, Groop PH. Influence of Postprandial Hyperglycemic Conditions on Arterial Stiffness in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Mar;101(3):1134-43. doi: 10.1210/jc.2015-3635. Epub 2016 Jan 5. |
| 26684274 | Derived | Muka T, de Jonge EA, Kiefte-de Jong JC, Uitterlinden AG, Hofman A, Dehghan A, Zillikens MC, Franco OH, Rivadeneira F. The Influence of Serum Uric Acid on Bone Mineral Density, Hip Geometry, and Fracture Risk: The Rotterdam Study. J Clin Endocrinol Metab. 2016 Mar;101(3):1113-22. doi: 10.1210/jc.2015-2446. Epub 2015 Dec 18. |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | T2DM With Albuminuria | T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. |
| BG002 | T2DM With Normal UAER | T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | T2DM Overall (Low Postprandial Glucose) | T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. |
| OG002 | T2DM With Albuminuria (High Postprandial Glucose) | T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). |
| OG003 | T2DM With Albuminuria (Low Postprandial Glucose) | T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. |
| OG004 | T2DM With Normal UAER (High Postprandial Glucose) | T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). |
| OG005 | T2DM With Normal UAER (Low Postprandial Glucose) | T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. |
|
|
|
| Primary | Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast | The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant. | Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation. | Posted | Least Squares Mean | 95% Confidence Interval | meters per second (m/sec) | 60 mins (post-breakfast) |
|
|
|
|
| Primary | Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast | The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant. | Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation. | Posted | Least Squares Mean | 95% Confidence Interval | meters per second (m/sec) | 120 mins (post-breakfast) |
|
|
|
|
| Primary | Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast | The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant. | Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation. | Posted | Least Squares Mean | 95% Confidence Interval | meters per second (m/sec) | 180 mins (post-breakfast) |
|
|
|
|
| Primary | Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast | The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant. | Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation. | Posted | Least Squares Mean | 95% Confidence Interval | meters per second (m/sec) | 240 mins (post-breakfast) |
|
|
|
|
| Secondary | Change in Pulse Wave Amplitude (PWA) | The PWA measured systemic arterial stiffness (augmentation index). PWA was reported as a percentage of systolic peak and calculated as the difference between second and first systolic peak in an ascending aortic pulse pressure waveform divided by the first systolic peak then multiplied by 100. The change in PWA from baseline [30-minute (min) pre-breakfast] is reported. | Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants with a baseline and a post-baseline PWA measurement at specified time point and no major protocol deviation. | Posted | Mean | Standard Deviation | percentage of systolic peak | 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) |
|
|
|
|
| Secondary | Change in Peripheral Artery Tonometry (PAT) | The PAT device is a pneumatic plethysmograph that applies uniform pressure to the surface of each finger tip and measures digital pulse amplitude. The PAT was reported as a percentage of pulse amplitude and expressed as the ratio of post deflation to baseline pulse amplitude in hyperemic finger divided by the same ratio in the contralateral finger that served as a control. The change in PAT from baseline [30-minute (min) pre-breakfast] is reported. | Enrolled healthy and randomized T2DM participants who had a baseline and a post-baseline PAT measurement at specified time point and no major protocol deviation. | Posted | Mean | Standard Deviation | percentage of pulse amplitude | 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast) |
|
|
|
|
| Secondary | Change in QT Interval on Electrocardiogram (ECG) | QT interval is a measure of time from the beginning of the QRS complex to the end of the T wave on an ECG during which contraction of the ventricles occurs. Changes in QT interval from baseline [30-minute (min) pre-breakfast] are reported. | Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline QT interval measurement at specified time point and no major protocol deviation. | Posted | Mean | Standard Deviation | milliseconds (msec) | 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) |
|
|
|
| Secondary | Change in Blood Glucose (BG) | Changes in BG from the baseline [30-minute (min) pre-breakfast] are reported. | Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and a post-baseline blood glucose measurement at specified time point and no major protocol deviation. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast) |
|
|
|
| Secondary | Change in Postprandial Pulse Wave Velocity (PWV) | The PWV measured arterial stiffness in the aortic and brachial arteries of healthy participants and T2DM participants. Changes in PWV from baseline [30-minute (min) pre-breakfast] are reported. | Enrolled healthy and randomized type 2 diabetes mellitus (T2DM) participants who had a baseline and post-baseline PWV measurement at specified time point and no major protocol deviation. | Posted | Mean | Standard Deviation | meters per second (m/sec) | 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | T2DM With Albuminuria | T2DM participants with abnormal UAER [albuminuria(defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. | 0 | 22 | 0 | 22 |
| EG002 | T2DM With Normal UAER | T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose. | 0 | 24 | 0 | 24 |
Not provided
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Brachial PWV (n=45, 45, 21, 22, 24, 23) |
|
| ANCOVA |
| 0.957 |
P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level. |
| LS Mean Difference |
| 0.03 |
| 2-Sided |
| 95 |
| -1.27 |
| 1.34 |
| No |
| Superiority or Other |
| ANCOVA | 0.513 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.41 | 2-Sided | 95 | -1.68 | 0.85 | No | Superiority or Other |
| ANCOVA | 0.623 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.09 | 2-Sided | 95 | -0.47 | 0.28 | No | Superiority or Other |
| ANCOVA | 0.916 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | 0.03 | 2-Sided | 95 | -0.51 | 0.57 | No | Superiority or Other |
| ANCOVA | 0.413 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 60-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.21 | 2-Sided | 95 | -0.73 | 0.31 | No | Superiority or Other |
| Brachial PWV (n=45, 45, 21, 22, 24, 23) |
|
| ANCOVA |
| 0.479 |
P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level. |
| LS Mean Difference |
| 0.57 |
| 2-Sided |
| 95 |
| -1.05 |
| 2.20 |
| No |
| Superiority or Other |
| ANCOVA | 0.825 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in aortic arteries. Significance was assessed at 2-sided 5% level. | LS Mean Difference | -0.18 | 2-Sided | 95 | -1.76 | 1.41 | No | Superiority or Other |
| ANCOVA | 0.378 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.20 | 2-Sided | 95 | -0.65 | 0.25 | No | Superiority or Other |
| ANCOVA | 0.553 | The p-value is for the LS mean difference (high minus low postprandial glucose) in PWV at 120 mins post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.19 | 2-Sided | 95 | -0.84 | 0.46 | No | Superiority or Other |
| ANCOVA | 0.512 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 120-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.20 | 2-Sided | 95 | -0.83 | 0.42 | No | Superiority or Other |
| Brachial PWV (n= 45, 45, 21, 22, 24, 23) |
|
| ANCOVA |
| 0.449 |
P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level. |
| LS Mean Difference |
| -0.44 |
| 2-Sided |
| 95 |
| -1.60 |
| 0.72 |
| No |
| Superiority or Other |
| ANCOVA | 0.792 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.15 | 2-Sided | 95 | -1.25 | 0.96 | No | Superiority or Other |
| ANCOVA | 0.493 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.16 | 2-Sided | 95 | -0.63 | 0.31 | No | Superiority or Other |
| ANCOVA | 0.091 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.58 | 2-Sided | 95 | -1.25 | 0.10 | No | Superiority or Other |
| ANCOVA | 0.425 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 180-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | 0.26 | 2-Sided | 95 | -0.39 | 0.90 | No | Superiority or Other |
| Brachial PWV (n= 45, 45, 21, 22, 24, 23) |
|
| ANCOVA |
| 0.784 |
P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level. |
| LS Mean Difference |
| -0.17 |
| 95 |
| -1.44 |
| 1.10 |
| No |
| Superiority or Other |
| ANCOVA | 0.197 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in aortic arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.79 | 2-Sided | 95 | -2.01 | 0.43 | No | Superiority or Other |
| ANCOVA | 0.122 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.40 | 2-Sided | 95 | -0.90 | 0.11 | No | Superiority or Other |
| ANCOVA | 0.246 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.43 | 2-Sided | 95 | -1.16 | 0.31 | No | Superiority or Other |
| ANCOVA | 0.298 | P-value is for LS mean difference (high minus low postprandial glucose) in PWV at 240-min post-breakfast in brachial arteries. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.37 | 2-Sided | 95 | -1.06 | 0.33 | No | Superiority or Other |
| 120-Min Post-Breakfast |
|
| 180-Min Post-Breakfast |
|
| 240-Min Post-Breakfast |
|
|
| ANCOVA |
The LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant. |
| 0.859 |
P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 60-min post-breakfast. Significance was assessed at the 2-sided 5% level. |
| LS Mean Difference |
| 0.25 |
| 2-Sided |
| 95 |
| -2.59 |
| 3.09 |
| No |
| Superiority or Other |
| ANCOVA | LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant. | 0.155 | P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -2.19 | 2-Sided | 95 | -5.25 | 0.87 | No | Superiority or Other |
| ANCOVA | LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant. | 0.685 | P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 120-min post-breakfast. Significance was assessed at 2-sided 5% level. | LS Mean Difference | -0.58 | 2-Sided | 95 | -3.46 | 2.30 | No | Superiority or Other |
| ANCOVA | LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant. | 0.292 | P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -1.84 | 2-Sided | 95 | -5.33 | 1.64 | No | Superiority or Other |
| ANCOVA | LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant. | 0.216 | P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 180-min post-breakfast. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | 2.04 | 2-Sided | 95 | -1.25 | 5.33 | No | Superiority or Other |
| ANCOVA | LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant. | 0.065 | P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -2.87 | 2-Sided | 95 | -5.92 | 0.18 | No | Superiority or Other |
| ANCOVA | LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant. | 0.954 | P-value is for LS mean difference (high minus low postprandial glucose) in change in PWA at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.08 | 2-Sided | 95 | -2.96 | 2.80 | No | Superiority or Other |
| 240-Min Post-Breakfast (n= 24, 21, 22, 23, 21) |
|
| ANCOVA |
LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant. |
| 0.004 |
P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 120-min post-breakfast. Significance was assessed at the 2-sided 5% level. |
| LS Mean Difference |
| 0.42 |
| 2-Sided |
| 95 |
| 0.14 |
| 0.69 |
| No |
| Superiority or Other |
| ANCOVA | LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant. | 0.584 | P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | -0.09 | 2-Sided | 95 | -0.41 | 0.23 | No | Superiority or Other |
| ANCOVA | LS mean was adjusted for age, BMI, visit, group, condition, group by condition, and random participant. | 0.436 | P-value is for LS mean difference (high minus low postprandial glucose) in change in PAT at 240-min post-breakfast. Significance was assessed at the 2-sided 5% level. | LS Mean Difference | 0.13 | 2-Sided | 95 | -0.19 | 0.44 | No | Superiority or Other |
| 120-Min Post-Breakfast (n=25, 21, 21, 24, 24) |
|
| 180-Min Post-Breakfast (n=25, 21, 21, 23 ,24) |
|
| 240-Min Post-Breakfast (n=25, 21, 21, 24, 24) |
|
| 110-Min Post-Breakfast (n= 25, 21, 22, 24, 24) |
|
| 170-Min Post-Breakfast (n= 25, 21, 22, 24, 24) |
|
| 230-Min Post-Breakfast (n= 25, 21, 22, 24, 24) |
|
| 120-Min Post-Breakfast (Aortic;n=22,21,22,23,22) |
|
| 180-Min Post-Breakfast (Aortic;n=23,21,22,23,22) |
|
| 240-Min Post-Breakfast (Aortic;n=23,21,22,23,22) |
|
| 60-Min Post-Breakfast (Brachial;n=23,21,22,24,23) |
|
| 120-Min Post-Breakfast (Brachial;n=22,21,22,24,23) |
|
| 180-Min Post-Breakfast (Brachial;n=24,21,22,24,23) |
|
| 240-Min Post-Breakfast (Brachial;n=23,21,22,24,23) |
|