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COMPLETED
NCT00894738

Measurement of Cardiometabolic Risk in Antipsychotic-Treated Children

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

Summary

The proposed study aims to begin the multi-step process of establishing the reliability and validity of hepatic triglyceride content (HTGC) and carotid artery intima-media thickness (IMT) as biomarkers of cardiometablic risk in children treated for mental illness. The distribution of HTGC and carotid IMT-proximate indicators of cardiometabolic risk-across a range of dual-energy X-ray absorptiometry (DEXA)-measured adiposity in children treated with antipsychotic agents will be characterized in comparison to healthy, untreated, non-psychiatric controls, in order to estimate effect sizes for future studies incorporating these markers. The ability of HTGC and IMT to predict cardiometabolic risk as measured by commonly-used laboratory tests, such as fasting lipids, liver function tests, C-reactive protein and serum fibrinogen, will be assessed.

Official title: Biomarkers of Cardiometabolic Risk in Children Treated With Antipsychotics: A Preliminary Study of Direct Measures

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

44

Start Date

2010-01-01

Completion Date

2016-06-01

Last Updated

2026-08-20

Healthy Volunteers

Yes

Interventions

PROCEDURE

Testing (MRS, US, DEXA, blood tests)

Magnetic Resonance Spectroscopy (MRS) of the liver to determine hepatic triglyceride content; ultrasound (US) of the carotid artery to determine intima-media thickness; dual energy X-ray absorptiometry (DEXA) to determine body composition; fasting lipids, fasting insulin, C-reactive protein, liver enzymes and fibrinogen levels.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States