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Children With Diabetes at Risk for Heart Disease.

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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

Study Description
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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.

Condition or disease
Diabetes Mellitus, Type 1 Diabetes Complications

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
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Identifying Children With Diabetes Type 1 at High Risk for Cardiovascular Disease.
Study Start Date : October 2014
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
blood samples will be collected through study completion

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children with diabetes type 1 and healthy children
Criteria

Inclusion Criteria:

Diabetes type 1 or Healthy

Exclusion Criteria:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02275091


Contacts
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Contact: Evgenia Gourgari, MD 2024441210
Contact: Kathryn Turner 2024442639

Locations
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United States, District of Columbia
Georgetown-Howard Universities Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Stephanie Gubb    202-444-1210      
Principal Investigator: Evgenia Gourgari, MD         
Sponsors and Collaborators
Georgetown University
Howard University
Investigators
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Principal Investigator: Evgenia Gourgari Georgetown University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Evgenia Gourgari, M.D., Assistant Professor of Pediatric Endocrinology, Georgetown University
ClinicalTrials.gov Identifier: NCT02275091    
Other Study ID Numbers: 2014-0755
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Keywords provided by Evgenia Gourgari, M.D., Georgetown University:
Children
Cholesterol
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Complications
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases