Pilot Study of Transcriptomic Alterations Associated with Antipsychotic-induced Metabolic Disorders in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- BMI-Z
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
BMI-Z
时间窗: Once, at recruitment
Body mass index, normalized by age and sex. Values below -1 indicate underweight, values below 1 indicate overweight.
次要结局
未报告次要终点