Arterial Stiffness in Type I Diabetes Mellitus

Arterial Stiffness Clinical Trial

Official title:

Acute Effect of a Mixed Meal With and Without Extra Insulin on Arterial Stiffness, a Prospective Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02218268
• Other study ID #: 201400553
• Secondary ID: 00093792
• Status: Completed
• Phase: N/A
• First received: August 8, 2014
• Last updated: August 13, 2015
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arterial Stiffness

Intervention

Other:
• Radial tonometry
A 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 and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.

Dietary Supplement:
• Boost
Subjects will drink a meal replacement drink (Boost) at the initial study visit and at the visit 3 months later.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Diabetes Action Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular risk factors.	Correlate radial artery stiffness with the influence of cardiovascular risk factors. A blood pressure and hemoglobin A1c will be obtained at the visits. Past lipid panel, family history (such as high blood pressure, stroke, high cholesterol and heart attacks), exercise, years of diabetes, stage of puberty will be reviewed at the visit.	baseline and 3 months	No
Primary	Arterial Stiffness	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. 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. One value with a quality index above 75 will be obtained at each study time point. A high-fidelity micromanometer (Millar Instruments, Houston, Texas) will be placed on the right radial artery and gentle pressure applied until a consistent waveform is produced.	baseline and 3 months	No
Secondary	Hemoglobin A1c	Correlate the acute effect of radial artery stiffness with hemoglobin A1c and in relation to years with type I diabetes. See first outcome measure on discussion of determining radial artery stiffness. Hemoglobin A1c will be measured with point of care device and years of diabetes based on history.	baseline and 3 months	No