Impact of Weight Loss Interventions on Multiorgan Health, Detected by Quantitative MRI, in Children and Young People With Severe Obesity.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Liver fat measured using quantitative MRI
研究概览
简要总结
The goal of this study is to quantify the body composition and organ fat distribution changes with obesity interventions in adolescents with severe obesity. The main question the investigators aim to answer is if there is improvement in organ health with weight loss intervention. The investigators will be comparing the degree of these changes between children being treated with GLP1 receptor agonists in addition to lifestyle changes and those managed with lifestyle changes alone. Participants will undergo MRI body composition at baseline and after 9 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to <18 years at the time of enrolment
- •BMI >99.6th centile or >2.67 SDS
- •Informed consent from parent(s) (or person with parental responsibility) and assent from the child or young person for participants aged less than 16 years (or)
- •Informed consent from the participant if aged ≥ 16 years.
排除标准
- •Body weight above upper limit of the scanner (>250 kilograms)
- •Needs general anaesthesia for the MRI scanning
- •Any contraindications for MRI- Metal implants/claustrophobia
- •Previous use of GLP-1 receptor agonist
- •Refusal to consent or refusal to assent from a competent older adolescent.
研究组 & 干预措施
Patients on GLP1 receptor agonist
Patients being treated with GLP1 receptor agonist in addition to lifestyle interventions
Patients not on GLP1 receptor agonist
Patients not being treated with GLP1 receptor agonist and only on lifestyle intervention
结局指标
主要结局
Change in Liver fat measured using quantitative MRI
时间窗: From enrollment to 9 months
Change in liver fat content from baseline to follow-up, quantified using MRI-derived proton density fat fraction (PDFF).
次要结局
- Changes to body composition assessed by MRI(Baseline to 9 months)
- Change in pancreatic fat assessed by MRI.(Baseline to 9 months)
- Changes in biochemical parameters-fasting glucose(9 months)
- Changes in biochemical parameters-HbA1C(9 months)