N/A
N=60
Arterial Stiffness in Type I Diabetes Mellitus
Arterial Stiffness in Youth With Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02218268 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: 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. — -4.5; -4.5; -4.3; -4.3 Percent of Pulse Pressure
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pre-meal bolus (Drug); No meal bolus (Drug)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
-4.5; -4.5; -4.3; -4.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02218268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.