Arterial Stiffness in Youth With Type 1 Diabetes
Conditions
Keywords
type I diabetes, healthy, children, adolescents, young adults
Brief summary
Using radial artery tonometry to study arterial stiffness, the plan is to study a cohort of 65 children with Type I diabetes mellitus. This prospective, crossover study will help determine if there is an acute increase in arterial stiffness in children with Type I diabetes mellitus who do not give extra insulin to cover a meal. This will give more support to show why it is so critical to bolus every time they eat and to bolus on time to decrease cardiovascular consequences of poorly controlled diabetes. The hypothesis is that giving insulin before a meal compared to not giving insulin before a meal will be associated with lower arterial stiffness in children with type I diabetes.
Detailed description
The subject will fast overnight (nothing to eat or drink for at least 8 hours). The subject will be asked to drink a mixed meal replacement drink (Boost) and will be randomized (like flipping a coin) to bolus insulin for the meal or to not bolus insulin using their standard insulin dose. 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. Radial tonometry is safe and does not hurt. A pen like probe is placed on the blood vessel of the wrist. When the machine reads a good wave form the computer will calculate the stiffness of the blood vessel. This test will be done along with the glucose checks; before drinking the meal replacement drink, and 1 and 2 hours after drinking the meal replacement drink. During the next study visit, the subject will repeat the exact same study described above. However, this time they will receive the other insulin assignment they were assigned during the first study (either bolus or no bolus).
Interventions
DRUGPre-meal bolus
Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost
DRUGNo meal bolus
Long Acting insulin as scheduled per usual routine (given once daily)
Sponsors
Diabetes Action Research and Education Foundation
University of Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* Type 1 diabetes based on clinical history * Basal-bolus insulin regimen * Duration of diabetes greater than 1 year * Blood glucose 65-200 mg/dL fasting
Exclusion criteria
* Use of metformin or any other hypoglycemic agents besides insulin * Use of anti-hypertensives * Caffeine or smoking within the past 24 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From baseline to one hour then 2 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All 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. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 24 Hour Washout | Physician Decision | 11 | 9 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 12.5 years STANDARD_DEVIATION 2.13 |
| Gender Female | 32 Participants |
| Gender Male | 28 Participants |
| HbA1c | 7.86 percentage STANDARD_DEVIATION 0.96 |
| Region of Enrollment United States | 60 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
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.
Time frame: From baseline to one hour then 2 hours
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pre-meal Bolus Then No Meal Bolus | 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 |
| Pre-meal Bolus Then No Meal Bolus | 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 |
| No Meal Bolus Then Pre-meal Bolus | 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 |
| No Meal Bolus Then Pre-meal Bolus | 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 |