Children With Diabetes at Risk for Heart Disease.

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ClinicalTrials.gov Identifier: NCT02275091

Recruitment Status : Recruiting

First Posted : October 27, 2014

Last Update Posted : April 5, 2019

See Contacts and Locations

Sponsor:

Collaborator:

Howard University

Information provided by (Responsible Party):

Evgenia Gourgari, M.D., Georgetown University

Study Description

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 Genetics related topics: Type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gourgari E, Ma J, Playford MP, Mehta NN, Goldman R, Remaley AT, Gordon SM. Proteomic alterations of HDL in youth with type 1 diabetes and their associations with glycemic control: a case-control study. Cardiovasc Diabetol. 2019 Mar 28;18(1):43. doi: 10.1186/s12933-019-0846-9.

Gourgari E, Playford MP, Campia U, Dey AK, Cogen F, Gubb-Weiser S, Mete M, Desale S, Sampson M, Taylor A, Rother KI, Remaley AT, Mehta NN. Low cholesterol efflux capacity and abnormal lipoprotein particles in youth with type 1 diabetes: a case control study. Cardiovasc Diabetol. 2018 Dec 19;17(1):158. doi: 10.1186/s12933-018-0802-0.

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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

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