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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
72
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.
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, Finland
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 180 mins (post-breakfast)
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast
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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.
Time frame: 240 mins (post-breakfast)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)