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Antipsychotics and Blood Vessel Function

NCT00585273 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 44

Last updated 2019-08-29

No results posted yet for this study

Summary

Over the last decade, second generation antipsychotics have been increasingly utilized. Since their introduction, however, atypical antipsychotics have been increasingly associated with significant metabolic complications including hyperlipidemia, insulin resistance/diabetes mellitus, and obesity. These metabolic complications increase the risk for cardiovascular disease in populations with an already elevated risk.

The initial goal of the proposed study is to identify early signs of endothelial dysfunction and vascular disease in those treated with atypical antipsychotics. The identification of early signs of vascular disease may further link metabolic complications with any cardiovascular risk. Demonstration of changes in vascular function associated with atypical antipsychotics represents an important identifiable intermediate of more long-term cardiovascular risk.

The second goal of the proposed study is to identify genetic factors that may be associated with the development of cardiovascular disease, which can later serve as a guide to predict risk. Accurate prediction of risk may facilitate the future development of an empirical, risk-based, individualized selection process for antipsychotic medications.

Aim 1: To quantify the role of antipsychotic-induced metabolic complications on the development of vascular disease using measures of endothelial function.

Hypothesis 1: Atypical antipsychotics will lead to greater impairments in endothelial function, evidenced by decreased flow-mediated dilation from baseline measures and compared with changes over time in controls. Medication-induced metabolic complications will be temporally associated with these impairments in endothelial function.

Aim 2: To investigate the role of candidate pharmacogenetic polymorphisms with cardiovascular and metabolic complications of atypical antipsychotics.

Hypothesis 2: Profiles of polymorphisms at receptors targeted by atypical antipsychotics will be associated with impaired cardiovascular function and metabolic complications.

Conditions

Sponsors & Collaborators

  • Jess G. Fiedorowicz

    lead OTHER

Principal Investigators

  • Jess G Fiedorowicz, M.D., Ph.D. · University of Iowa

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00585273 on ClinicalTrials.gov