Arterial Stiffness in Type I Diabetes Mellitus

Completed

Conditions studied: Arterial Stiffness in Youth With Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT02218268

Run by

University of Florida

People needed

60

Starts

2014-10-01

Expected to finish

2015-08-01

Last updated by the study team

2017-02-06

Who can join

Age: 8 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Use of metformin or any other hypoglycemic agents besides insulin
• Use of anti-hypertensives
• Caffeine or smoking within the past 24 hours

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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