| Trial ID: | L3771 |
| Source ID: | NCT02218268
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| Associated Drug: |
Pre-Meal Bolus
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| Title: |
Arterial Stiffness in Type I Diabetes Mellitus
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| Acronym: |
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| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02218268/results
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| Conditions: |
Arterial Stiffness in Youth With Type 1 Diabetes
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| Interventions: |
DRUG: Pre-meal bolus|DRUG: No meal bolus
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| Outcome Measures: |
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., From baseline to one hour then 2 hours |
|
| Sponsor/Collaborators: |
Sponsor: University of Florida | Collaborators: Diabetes Action Research and Education Foundation
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| Gender: |
ALL
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| Age: |
CHILD, ADULT
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| Phases: |
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| Enrollment: |
60
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| Study Type: |
OBSERVATIONAL
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| Study Designs: |
Observational Model: |Time Perspective: p
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| Start Date: |
2014-10
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| Completion Date: |
2015-08
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| Results First Posted: |
2017-02-06
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| Last Update Posted: |
2017-02-06
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| Locations: |
University of Florida, Gainesville, Florida, 32610, United States
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| URL: |
https://clinicaltrials.gov/show/NCT02218268
|
