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NCT01508598 · ClinicalTrials.gov registry record
Validation of Circulating Endothelial Cells and Microparticles in Youth
A clinical trial, sponsored by University of Minnesota.
- Terminated
- Registry status
- 390
- Enrollment target
NCT01508598: Clinical Trial study, sponsored by University of Minnesota.
NCT01508598 is a clinical trial that was terminated before completion, run by University of Minnesota. The registered enrollment target is 390 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01508598 was terminated before completion, sponsored by University of Minnesota.
- TERMINATED
- Registry status
- 390 participants
- Enrollment target
Study Summary
Identification and validation of early chronic disease biomarkers in children is of paramount importance especially in the burgeoning arena of pediatric obesity research. Despite the presence of risk factors, few obese children develop overt cardiovascular disease (CVD) early in life. However, because CVD is a cumulative process occurring over time, identifying the earliest signs in order to intervene sooner may have a large impact on slowing its progression. Endothelial activation is one of the earliest detectable signs of the beginnings of CVD. However, accurately quantifying endothelial health in children has proven to be a major challenge. Direct measures of endothelial cell biology, such as circulating endothelial cells (CEC) and endothelial microparticles (EMP), have been extensively studied in adults and are associated with vascular diseases, CVD risk factors, and CVD events. Despite being well-validated in adults, CEC and EMP have not been formally evaluated as disease biomarkers in children and adolescents. Pediatric obesity is an ideal condition in which to validate CEC and EMP as disease biomarkers since adiposity in childhood is associated with CVD, type 2 diabetes mellitus, and premature death, later in life. The investigators primary focus in this study will be the evaluation of CEC and EMP as biomarkers of CVD risk and whether substantial changes in weight affect these biomarkers. The investigators propose to evaluate the change in levels of CEC and EMP in response to substantial weight loss in 32 adolescents with extreme obesity undergoing elective, clinically-indicated bariatric surgery.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2012-02 |
| Est. Completion | 2018-01-02 |
Why NCT01508598 stopped before completion
NCT01508598 is an observational study that tracks outcomes without assigning an intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01508598 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01508598 about?
NCT01508598 is a clinical study titled "Validation of Circulating Endothelial Cells and Microparticles in Youth". Identification and validation of early chronic disease biomarkers in children is of paramount importance especially in the burgeoning arena of pediatric obesity research. Despite the presence of risk factors, few obese children develop overt cardiovascular disease (CVD) early in life. However, becau...
What is the current status of trial NCT01508598?
This trial is currently terminated. The enrollment target is 390 participants. The study started on 2012-02. Estimated completion is 2018-01-02.
Who is sponsoring clinical trial NCT01508598?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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