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NCT02218268 · ClinicalTrials.gov registry record
Arterial Stiffness in Type I Diabetes Mellitus
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 60
- Enrollment target
NCT02218268: Completed study, sponsored by University of Florida.
NCT02218268 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02218268 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Pre-meal bolus
- DRUG No meal bolus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-08 |
What the finished NCT02218268 record still lists
NCT02218268 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Pre-meal bolus is the first listed.
NCT02218268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02218268 about?
NCT02218268 is a clinical study titled "Arterial Stiffness in Type I Diabetes Mellitus". 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 e...
What is the current status of trial NCT02218268?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2014-10. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02218268?
The interventions under investigation include: Pre-meal bolus (DRUG), No meal bolus (DRUG).
Who is sponsoring clinical trial NCT02218268?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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