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Arterial Stiffness in Type I Diabetes Mellitus

NCT02218268 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2017-02-06

Study results available
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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.

Conditions

  • Arterial Stiffness in Youth With Type 1 Diabetes

Interventions

DRUG

Pre-meal bolus

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

DRUG

No meal bolus

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

Sponsors & Collaborators

  • Diabetes Action Research and Education Foundation

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Michael Haller, MD · University of Florida

Eligibility

Min Age
8 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02218268 on ClinicalTrials.gov