MR Imaging of Fat Deposition in Adolescents With First Time Antipsychotic Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in hepatic and visceral adipose tissue from baseline to 3 months
研究概览
简要总结
This study will focus on a population of antipsychotic (AP) naïve adolescents and young adults and will measure fat accumulation in relation to exposure to atypical antipsychotic medications.
详细描述
Atypical Antipsychotics (AAPs) are known to cause metabolic dysfunction, and adolescents are especially vulnerable to this effect. The anthropometric measures routinely used to monitor these metabolic side effects may, in fact, underestimate risk in the pediatric population as they are not a good index of hepatic and visceral adipose tissue.
This study will measure fat accumulation over a 12 week period in adolescents and young adults taking an AAP for the first time. MRI imaging will measure hepatic, and visceral adipose tissue at baseline and study end. An Oral Glucose Tolerance Test will measure glucose resistance and insulin sensitivity. In an exploratory fashion, investigators will also image the brain to assess for volumetric changes which may occur in association with AAP treatment and changes in metabolic indices.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AP naïve or AP-free for 3 months or greater
- •prescribed an AP for treatment
- •age 12-35
- •using contraceptive (females of child bearing age)
排除标准
- •currently taking AP or been taking AP for greater than 1 week within the past 3 months
- •pregnant or planning to become pregnant
- •eating disorder (active or previous)
- •clinical or laboratory evidence of uncompensated cardiovascular, endocrine, haematological, or pulmonary disease
- •major medical or surgical event in the preceding 3 months
- •acute suicidal risk
结局指标
主要结局
Change in hepatic and visceral adipose tissue from baseline to 3 months
时间窗: Baseline and 3 months
Adipose tissue is measured by an MRI. Fat content will be compared between baseline and study end (3 months).
次要结局
- Change in insulin sensitivity from baseline to 3 months.(Baseline and 3 months)
- Body Mass Index (BMI)(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change in weight(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change in appetite(Baseline and 3 months)
- Change in glucose tolerance from baseline to 3 months.(Baseline and 3 months)
研究者
Margaret Hahn
MD, PhD, FRCPC
Centre for Addiction and Mental Health