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Children With Diabetes at Risk for Heart Disease.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02275091
Recruitment Status : Unknown
Verified April 2019 by Evgenia Gourgari, M.D., Georgetown University.
Recruitment status was:  Recruiting
First Posted : October 27, 2014
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Howard University
Information provided by (Responsible Party):
Evgenia Gourgari, M.D., Georgetown University

Tracking Information
First Submitted Date October 23, 2014
First Posted Date October 27, 2014
Last Update Posted Date April 5, 2019
Study Start Date October 2014
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 3, 2019)
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
Original Primary Outcome Measures
 (submitted: October 24, 2014)
Lipoprotein profile [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Children With Diabetes at Risk for Heart Disease.
Official Title Identifying Children With Diabetes Type 1 at High Risk for Cardiovascular Disease.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood samples will be collected through study completion
Sampling Method Probability Sample
Study Population Children with diabetes type 1 and healthy children
Condition
  • Diabetes Mellitus, Type 1
  • Diabetes Complications
Intervention Not Provided
Study Groups/Cohorts
  • Diabetes
    Children with diabetes type 1 , 12-21 years old
  • Healthy
    Healthy children 12-21 years old
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 26, 2018)
240
Original Estimated Enrollment
 (submitted: October 24, 2014)
120
Estimated Study Completion Date October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Diabetes type 1 or Healthy

Exclusion Criteria:

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

Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02275091
Other Study ID Numbers 2014-0755
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Evgenia Gourgari, M.D., Georgetown University
Study Sponsor Georgetown University
Collaborators Howard University
Investigators
Principal Investigator: Evgenia Gourgari Georgetown University
PRS Account Georgetown University
Verification Date April 2019