Children With Diabetes at Risk for Heart Disease.
Identifying Children With Diabetes Type 1 at High Risk for Cardiovascular Disease.
1 other identifier
observational
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 23, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedApril 5, 2019
April 1, 2019
6 years
October 23, 2014
April 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
Diabetes
Children with diabetes type 1 , 12-21 years old
Healthy
Healthy children 12-21 years old
Eligibility Criteria
Children with diabetes type 1 and healthy children
You may qualify if:
- Diabetes type 1 or Healthy
You may not qualify if:
- Taking medications that lower cholesterol Duration of type 1 diabetes \< 1 year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- Howard Universitycollaborator
Study Sites (1)
Georgetown-Howard Universities Center
Washington D.C., District of Columbia, 20007, United States
Related Publications (2)
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.
PMID: 30922315DERIVEDGourgari 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.
PMID: 30567548DERIVED
Biospecimen
blood samples will be collected through study completion
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evgenia Gourgari
Georgetown University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatric Endocrinology
Study Record Dates
First Submitted
October 23, 2014
First Posted
October 27, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
April 5, 2019
Record last verified: 2019-04