Identifying Children With Diabetes Type 1 at High Risk for Cardiovascular Disease.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Georgetown University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- small LDL particles
Study Overview
Brief Summary
Patients with type 1 diabetes type 1 (DM1) have increased risk of death due to heart disease and stroke. These cardiovascular conditions (CVD) are the leading cause of death in patients with DM1 younger than 40 years of age and up to 35% of all persons with DM1 will die before age 55 from CVD. Strategies are needed to help identify adolescents with DM1 at risk for CVD so that interventions to prevent heart disease and stroke can be undertaken.
Detailed Description
Patients with type 1 diabetes and healthy controls will have evaluation of their lipid profile. Arterial stiffness, heart rate variability and adiposity measurements will be done in patients with type 1 diabetes and healthy controls. Blood pressure and heart rate will be recorded. 50 ml of urine will be collected from patients and controls.
All studies will be performed as a single outpatient visit at Georgetown University.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 12 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Diabetes type 1 or Healthy
Exclusion Criteria
- •Taking medications that lower cholesterol Duration of type 1 diabetes < 1 year.
Outcomes
Primary Outcomes
small LDL particles
Time Frame: This is an observational cross sectional study. Samples will be collected through study completion, on average of 6 years duration.
Blood test, based on NMR
Secondary Outcomes
No secondary outcomes reported
Investigators
Evgenia Gourgari, M.D.
Assistant Professor of Pediatric Endocrinology
Georgetown University