Physiopathology of Behavioral Addictions and Biomarkers: microRNAs Implication - MiRACle : a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Blood miR-10a-5p expression
研究概览
简要总结
The goal of this observational study is to evaluate the expression of miR-10a-5p in the blood in patients with sexual addiction or food addiction. The main question it aims to answer is : To determine whether adults patients with SA or FA exhibit a distinct blood miR-10a-5p expression profile compared with matched healthy controls.
For all participants, one blood sample will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients with FA:
- •Male and females ≥ 18 years old
- •Already in care or newly initiating care
- •Participating to EVALADD cohort
- •Current diagnosis of FA
- •Oral consent provided
- •Affiliated with French social security system or beneficiary from such system
- •For healthy controls matched to patients with FA:
- •Male and females ≥ 18 years old
- •Oral consent provided
- •Affiliated with French social security system or beneficiary from such system
- •For patients with SA:
- •Male ≥ 18 years old
- •Already in care or newly initiating care
- •Participating to EVALADD cohort
- •Current diagnosis of SA
- •Oral consent provided
- •Affiliated with French social security system or beneficiary from such system
- •For healthy controls matched to patients with SA:
- •Male ≥ 18 years old
- •Oral consent provided
- •Affiliated with French social security system or beneficiary from such system
排除标准
- •For patients with FA:
- •Presence of a current diagnosis of SA
- •Presence of any current addictive disorder (substance [except tobacco] use disorders, gambling disorder, gaming disorder)
- •Presence of any current instable psychiatric disorder (requiring the initiation or adapation of medication)
- •Pregnancy or breastfeeding woman
- •Trusteeship or curatorship
- •Major cognitive impairment
- •Not fluent in French
- •For patients with SA:
- •Presence of a current diagnosis of FA
- •Presence of any current addictive disorder (substance [except tobacco] use disorders, gambling disorder, gaming disorder)
- •Presence of any current instable psychiatric disorder (requiring the initiation or adapation of medication)
- •Trusteeship or curatorship
- •Major cognitive impairment
- •Not fluent in French
- •For healthy controls:
- •Without a current diagnosis of FA
- •Without a current diagnosis of SA
- •Presence of any current addictive disorder (substance [except tobacco] use disorders, gambling disorder, gaming disorder)
- •Presence of any current instable psychiatric disorder (requiring the initiation or adapation of medication)
- •Pregnancy or breastfeeding woman
- •Trusteeship or curatorship
- •Major cognitive impairment
- •Not fluent in French
研究组 & 干预措施
Patients with addiction
Patients with food addiction (FA) or sexual addiction
干预措施: blood sampling (Biological)
Healthy controls
Healthy controls matched on sex and age to patients with food addiction or sexual addiction
干预措施: blood sampling (Biological)
结局指标
主要结局
Blood miR-10a-5p expression
时间窗: 3 months
Quantitative comparison of blood miR-10a-5p expression levels between patients with SA or FA and matched healthy controls.
次要结局
- Blood additional circulating miRs expression(3 months)
- Clinical Characteristics(3 months)
