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| ID | Type | Description | Link |
|---|---|---|---|
| 00093792 | Other Identifier | University of Florida |
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| Name | Class |
|---|---|
| Diabetes Action Research and Education Foundation | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-meal bolus | Drug | Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to one hour then 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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University of Florida diabetes clinic and the Florida Camp for Children and Youth with Diabetes. Subjects had type 1 diabetes for at least one year, were using a basal-bolus insulin regimen, and were not taking oral hypoglycemic agents or antihypertensive drugs.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Haller, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Phase (2 Hours) |
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| 24 Hour Washout |
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| Final Phase (2 Hours) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | 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. | Posted | Mean | 95% Confidence Interval | Percent of Pulse Pressure | From baseline to one hour then 2 hours |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. This is a crossover study and all participants will take place in this arm after 3 months of their visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Haller | University of Florida | 352-265-0111 | hallemj@peds.ufl.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| No meal bolus | Drug | Long Acting insulin as scheduled per usual routine (given once daily) |
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| NOT COMPLETED |
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| years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HbA1c | Mean | Standard Deviation | percentage |
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| 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. |
| OG001 | 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. |
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| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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, This is a crossover study and all participants will take place in this arm after 3 months of their visit. | 0 | 30 | 0 | 30 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |