Children With Diabetes at Risk for Heart Disease.
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02275091 |
Recruitment Status :
Recruiting
First Posted : October 27, 2014
Last Update Posted : April 5, 2019
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Condition or disease |
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Diabetes Mellitus, Type 1 Diabetes Complications |
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 |
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 |

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

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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 |
Inclusion Criteria:
Diabetes type 1 or Healthy
Exclusion Criteria:
Taking medications that lower cholesterol Duration of type 1 diabetes < 1 year.

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
Contact: Evgenia Gourgari, MD | 2024441210 | ||
Contact: Kathryn Turner | 2024442639 |
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 |
Principal Investigator: | Evgenia Gourgari | Georgetown University |
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 |
Children Cholesterol |
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Complications Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |