Actively Recruiting

Age: 5Years - 17Years
All Genders
NCT06814314

AP Metabolism Transcriptomics

Led by IRCCS Eugenio Medea · Updated on 2025-02-07

100

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

It is known from the literature that treatment with antipsychotic drugs (AP) induces, even before changes in blood chemistry parameters, changes in gene transcription that are evident at the level of peripheral blood mononuclear cells. In this pilot study we intend to evaluate the transcriptomic profile of children and adolescents who are undergoing treatment with antipsychotics and show metabolic disorders, in order to compare it to the profile of similar patients who do not use antipsychotics, but show metabolic disorders, or who use antipsychotics, but do not show metabolic disorders. The hypothesis is that a different transcriptomic profile can be identified between the three populations under study, such as to allow to hypothesize that a series of transcripts can be used as early biomarkers of whether treatment with antipsychotics can induce metabolic disorders in the individual patient or not. This information could be used to improve the management of antipsychotic therapies in the direction of personalized medicine, reducing metabolic risks.

CONDITIONS

Official Title

AP Metabolism Transcriptomics

Who Can Participate

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 5 and 17 years
  • Group 1: antipsychotic users with metabolic disorders
  • Group 2: antipsychotic users without metabolic disorders
  • Group 3: non-antipsychotic users with metabolic disorders
  • Antipsychotic use defined as daily use for at least 3 months prior to enrollment
  • Metabolic disorders defined by at least one of the following: BMI-Z > +1, waist circumference > 90th percentile, blood pressure > 90th percentile, fasting blood glucose > 99 mg/dl, fasting triglycerides > 149 mg/dl, fasting cholesterol < 41 mg/dl
  • Patients without metabolic disorders do not meet any of the above criteria
Not Eligible

You will not qualify if you...

  • Diagnosed genetic conditions known to alter energy metabolism or nutrition
  • Diagnosed eating disorders
  • Habitual use of supplements known to alter energy metabolism or nutrition
  • Concomitant use of drugs known to alter energy metabolism or nutrition

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Eugenio Medea

Bosisio Parini, LC, Italy, 23842

Actively Recruiting

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Research Team

M

Marco Pozzi, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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