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

NCT00894738 | Completed Results

• 1 other identifier: 56790
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Disorders

Keywords

pediatric; mental illness; antipsychotic; cardiometabolic risk; Antipsychotic agents; Mental disorders diagnosed in childhood

Outcome Measures

Primary Outcomes (2)

• Carotid Artery Intima-media Thickness Measured by Ultrasonography.

  Week 1

• Intrahepatic Triglyceride Content (IHTG) Measure by Liver Magnetic Resonance Spectroscopy.

  Week 1

Study Arms (2)

antipsychotic treated

Children with psychiatric diagnoses who are currently treated with antipsychotic medications.

Procedure: Testing (MRS, US, DEXA, blood tests)

healthy control

Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy.

Procedure: Testing (MRS, US, DEXA, blood tests)

Interventions

Testing (MRS, US, DEXA, blood tests) PROCEDURE

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.

antipsychotic treated; healthy control

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children ages 6-18 who are currently being treated for a psychiatric condition with an antipsychotic medication, and age- and gender-matched healthy controls who are not treated with an antipsychotic medication.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Some routine blood tests to assess glucose and lipid control and liver function, as well as an additional hepatitis screen if subjects have a history of hepatitis. Approximately 42 ml (3 tablespoons) of blood will be obtained.

MeSH Terms

Conditions

Mental Disorders; Neurodevelopmental Disorders

Interventions

Absorptiometry, Photon; Hematologic Tests

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Clinical Laboratory Techniques

Results Point of Contact

• Title: Dr. Ginger Nicol
• Organization: Washington University School of Medicine

nicolg@psychiatry.wustl.edu

(314) 362-2461

Study Officials

• Ginger E Nicol, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 7, 2009
• Study Start: January 1, 2010
• Primary Completion: March 31, 2016
• Study Completion: June 1, 2016
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-06

Locations

US (1)