Trial Outcomes & Findings for Arterial Stiffness in Type I Diabetes Mellitus (NCT NCT02218268)

Last Updated: 2017-02-06

Results Overview

Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

From baseline to one hour then 2 hours

Results posted on

2017-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	Pre-meal Bolus Then No Meal Bolus A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.	No Meal Bolus Then Pre-meal Bolus A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
First Phase (2 Hours) STARTED	30	30
First Phase (2 Hours) COMPLETED	30	30
First Phase (2 Hours) NOT COMPLETED	0	0
24 Hour Washout STARTED	30	30
24 Hour Washout COMPLETED	19	21
24 Hour Washout NOT COMPLETED	11	9
Final Phase (2 Hours) STARTED	19	21
Final Phase (2 Hours) COMPLETED	19	21
Final Phase (2 Hours) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pre-meal Bolus Then No Meal Bolus A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.	No Meal Bolus Then Pre-meal Bolus A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
24 Hour Washout Physician Decision	11	9

Baseline Characteristics

Arterial Stiffness in Type I Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=60 Participants This is a crossover study of youth with Diabetes on a stable basal bolus insulin regimen. They will be randomized either receive a pre-meal insulin bolus in conjunction with their Basal insulin bolus or receive their standard of care basal insulin bolus only. A mixed meal replacement (Boost) will be consumed. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
Age, Continuous	12.5 years STANDARD_DEVIATION 2.13 • n=5 Participants
Gender Female	32 Participants n=5 Participants
Gender Male	28 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants
HbA1c	7.86 percentage STANDARD_DEVIATION 0.96 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline to one hour then 2 hours

Outcome measures

Outcome measures
Measure	Pre-meal Bolus Then No Meal Bolus n=19 Participants A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.	No Meal Bolus Then Pre-meal Bolus n=21 Participants A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.
Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin. Difference of mean AI75 1 hour after	-4.5 Percent of Pulse Pressure Interval -7.97 to -1.1	-4.5 Percent of Pulse Pressure Interval -7.97 to -1.1
Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin. Difference of mean AI75 2 hours after	-4.3 Percent of Pulse Pressure Interval -8.9 to 0.2	-4.3 Percent of Pulse Pressure Interval -8.9 to 0.2

Adverse Events

Pre-meal Bolus Then No Meal Bolus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Meal Bolus Then Pre-meal Bolus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Haller

University of Florida

Phone: 352-265-0111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place