Arterial Stiffness in Type I Diabetes Mellitus

NCT ID: NCT02218268

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-08-31

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).

Conditions

Arterial Stiffness in Youth With Type 1 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre-meal bolus then No meal bolus

A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. 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.

Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. 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

Pre-meal bolus

Intervention Type: DRUG

Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost

No meal bolus

Intervention Type: DRUG

Long Acting insulin as scheduled per usual routine (given once daily)

No meal bolus then Pre-meal bolus

A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. 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.

Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. 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

Pre-meal bolus

Intervention Type: DRUG

Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost

No meal bolus

Intervention Type: DRUG

Long Acting insulin as scheduled per usual routine (given once daily)

Interventions

Pre-meal bolus

Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost

Intervention Type: DRUG

No meal bolus

Long Acting insulin as scheduled per usual routine (given once daily)

Intervention Type: DRUG

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diabetes Action Research and Education Foundation

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Haller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

00093792

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201400553

Identifier Type: -

Identifier Source: org_study_id