NCT01188083已完成不适用
Effects of Dietary Fructose Reduction in Children With Hepatic Steatosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Hepatic Fat
研究概览
简要总结
Primary Objectives:
- To determine whether a 4 week reduction in dietary fructose intake improves hepatic steatosis in overweight children who have a baseline high fructose consumption and hepatic steatosis.
- To determine if a 4 week reduction of dietary fructose improves fasting plasma triglycerides, free fatty acids, very low-density lipoprotein, insulin and glucose as well as post-prandial levels in response to a high fructose meal.
- To determine if a 4 week reduction of dietary fructose improves markers of oxidative stress.
Study Design: A blinded randomized study comparing glucose beverages to isocaloric fructose beverages administered over 4 weeks.
详细描述
Planned Sample Size: Phase 1) 96 subjects Phase 2) 40 subjects
Patient Population: Overweight Hispanic children with non-alcoholic fatty-liver disease age 11 to 18 years who are stable and not taking any chronic medication with no recent acute illnesses.
Definitions:
- BMI >95th %tile for age and gender
- Self-identified as Hispanic/Latino
- Baseline hepatic fat fraction > 10% (Have nonalcoholic fatty liver disease)
- Sweetened beverage intake of at least 24 ounces/day
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 85th %tile
- •Self identified as Hispanic
- •Age 11-18 years
- •Baseline hepatic fat fraction >8%
- •Self reported sugar beverage intake of at least 24 oz (equivalent to 3 sugar sweetened drinks per day).
排除标准
- •Currently attempting weight gain or weight loss
- •Cirrhosis visible on baseline MRI
- •Renal insufficiency found on screening labs (creatinine > 2)
- •Recent acute illness within past 4 weeks (defined by fever > 100.4ºF)
- •Pregnancy
- •Chronic illness requiring medication including diabetes
- •Fasting glucose >120 on screening labs
结局指标
主要结局
Hepatic Fat
时间窗: 2 & 4 Weeks
次要结局
- Plasma Triglycerides(2 & 4 Weeks)
研究者
Miriam Vos, MD
Principal Investigator
Emory University
研究点 (2)
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