Clinical trial NCT02218268: Arterial Stiffness in Type I Diabetes Mellitus
Official title: Acute Effect of a Mixed Meal With and Without Extra Insulin on Arterial Stiffness, a Prospective Randomized Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Stiffness in Youth With Type 1 Diabetes
Keywords: type I diabetes
healthy
children
adolescents
young adults
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Diabetes Action Research and Education Foundation
First posted: 2014-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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).

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

Primary outcomes:
measure: 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.
timeFrame: From baseline to one hour then 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michael Haller, MD
role: PRINCIPAL_INVESTIGATOR
References: