Children With Diabetes at Risk for Heart Disease.

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Identifying Children With Diabetes Type 1 at High Risk for Cardiovascular Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02275091
• Other study ID #: 2014-0755
• Status: Recruiting
• Start date: October 2014
• Est. completion date: October 2020

Study information

• Verified date: April 2019
• Source: Georgetown University
• Contact: Evgenia Gourgari, MD
• Phone: 2024441210
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

Inclusion Criteria:

Diabetes type 1 or Healthy

Exclusion Criteria:

Taking medications that lower cholesterol Duration of type 1 diabetes < 1 year.

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Locations

Country	Name	City	State
United States	Georgetown-Howard Universities Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Howard University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	small LDL particles	Blood test, based on NMR	This is an observational cross sectional study. Samples will be collected through study completion, on average of 6 years duration.