Children With Diabetes at Risk for Heart Disease.

April 3, 2019 updated by: Evgenia Gourgari, M.D., Georgetown University

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Evgenia Gourgari, MD
  • Phone Number: 2024441210

Study Contact Backup

  • Name: Kathryn Turner
  • Phone Number: 2024442639

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown-Howard Universities Center
        • Contact:
          • Stephanie Gubb
          • Phone Number: 202-444-1210
        • Principal Investigator:
          • Evgenia Gourgari, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with diabetes type 1 and healthy children

Description

Inclusion Criteria:

Diabetes type 1 or Healthy

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Diabetes
Children with diabetes type 1 , 12-21 years old
Healthy
Healthy children 12-21 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
This is an observational cross sectional study. Samples will be collected through study completion, on average of 6 years duration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Howard University

Investigators

  • Principal Investigator: Evgenia Gourgari, Georgetown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

October 23, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0755

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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