AP Metabolism Transcriptomics

NCT06814314 | Recruiting

• 1 other identifier: 9/24 (ex 995)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neurodevelopmental Disorders; Irritability

Keywords

antipsychotic drugs; dyslipidemia; pre-diabetes; obesity; transcriptomics

Outcome Measures

Primary Outcomes (1)

• BMI-Z

  Body mass index, normalized by age and sex. Values below -1 indicate underweight, values below 1 indicate overweight.

  Once, at recruitment

Study Arms (3)

AP+ / MetS+

Persons using antipsychotic drugs and meeting diagnostic criteria for the metabolic syndrome

Diagnostic Test: Transcriptomic investigation

AP+ / MetS-

Persons using antipsychotic drugs not meeting diagnostic criteria for the metabolic syndrome

Diagnostic Test: Transcriptomic investigation

AP- / MetS+

Persons meeting diagnostic criteria for the metabolic syndrome not using antipsychotic drugs

Diagnostic Test: Transcriptomic investigation

Interventions

Transcriptomic investigation DIAGNOSTIC_TEST

Transcriptomic investigation followed by ontology classification

AP+ / MetS+; AP+ / MetS-; AP- / MetS+

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Persons with metabolic syndrome and/or users of antipsychotic drugs

You may qualify if:

• age 5-17 years;
• group 1: antipsychotic users with metabolic disorders;
• group 2: antipsychotic users without metabolic disorders;
• group 3: non-antipsychotic users with metabolic disorders. The definition of antipsychotic use includes daily use for at least 3 months prior to enrollment.
• The definition of metabolic disorders includes: BMI-Z for age, sex and height \> +1 Waist circumference \> 90th percentile for age, sex and height Diastolic or systolic blood pressure \> 90th percentile for age, sex and height Fasting blood glucose \> 99 mg/dl Fasting triglycerides \> 149 mg/dl Fasting cholesterol \< 41 mg/dl.
• Patients with metabolic disorders are defined as those who meet at least one of the above criteria.
• Patients without metabolic disorders are defined as those who do not present any of the above criteria.

You may not qualify if:

• presence of diagnosed genetic conditions known to alter energy metabolism and/or nutrition;
• presence of diagnosed eating disorders;
• habitual use of supplements known to alter energy metabolism and/or nutrition;
• concomitant use of drugs known to alter energy metabolism and/or nutrition.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders; Dyslipidemias; Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

Mental Disorders; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Glucose Metabolism Disorders; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marco Pozzi, PhD

CONTACT

031877919; marco.pozzi@lanostrafamiglia.it

Study Design

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

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: April 30, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

IT (1)