Children With Diabetes at Risk for Heart Disease.

• ClinicalTrials.gov Identifier: NCT02275091
• Recruitment Status: Unknown
• First Posted: October 27, 2014
• Last Update Posted: April 5, 2019
• Sponsor: Georgetown University
• 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 ]
• 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 *

• 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.

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

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