Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF
研究概览
简要总结
This research study intends to learn about whether early intervention can help to prevent non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to join the study. Patients who agree to participate in the study will be randomized into either the intervention group or the control group. The intervention group will follow a low-fructose diet. In addition, participants will be asked to return to the clinic for 4 follow-up visits during a 6-month interval.
详细描述
This will be a prospective, randomized, controlled trial for obese adolescents. Sixty obese youth (male and female), age 11-17 years with BMI >95 %tile for age and sex and one parent/guardian will be recruited for inclusion into the study at an initial pediatric fitness clinic visit. Consented subjects will be stratified by gender and ethnicity and randomized into low fructose or standard weight loss dietary intervention groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •11-17 years of age
- •BMI >95%tile for age and sex
- •Being seen for an initial clinic visit at the UW Pediatric Fitness Clinic
- •Parent willing to participate in study
排除标准
- •History of chronic disease that effects hepatic or renal function including: Type 1 or Type 2 diabetes mellitus, known liver disease or other chronic illness.
结局指标
主要结局
Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF
时间窗: 6 months
次要结局
- PNPLA3 genotype(6 months)
- Novel free breathing hepatic MR PDFF protocol(6 months)
- Metabolic biomarkers(6 months)