Children With Diabetes at Risk for Heart Disease.

NCT ID: NCT02275091

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1 Diabetes Complications

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diabetes

Children with diabetes type 1 , 12-21 years old

No interventions assigned to this group

Healthy

Healthy children 12-21 years old

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Diabetes type 1 or Healthy

Exclusion Criteria

Taking medications that lower cholesterol Duration of type 1 diabetes \< 1 year.
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Howard University

OTHER

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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Evgenia Gourgari, M.D.

Assistant Professor of Pediatric Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evgenia Gourgari

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Georgetown-Howard Universities Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Evgenia Gourgari, MD

Role: CONTACT

2024441210

Kathryn Turner

Role: CONTACT

2024442639

Facility Contacts

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Stephanie Gubb

Role: primary

202-444-1210

References

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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.

Reference Type DERIVED
PMID: 30922315 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30567548 (View on PubMed)

Other Identifiers

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2014-0755

Identifier Type: -

Identifier Source: org_study_id

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