Randomized Controlled Trial Comparing the Effects of a Low Glycemic Load Diet With a Low Fat Diet on Hepatic Steatosis in Overweight Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- percent liver fat as determined by nMR spectroscopy
研究概览
简要总结
There has been a recent increase in incidence of obesity and its associated morbidities, including T2 DM, hypertension and hepatic steatosis. Hepatic steatosis is a precursor to non-alcoholic steatohepatitis, cirrhosis and end-stage liver disease. The 1st reported case of pediatric hepatic steatosis was in 1980 and it is now affects 30-77% of overweight children. In addition to its association with obesity, hepatic steatosis has been associated with the metabolic syndrome, insulin resistance, and post-prandial hyperglycemia. Current treatment of hepatic steatosis includes weight loss with a hypocaloric low fat diet. Given the association with insulin resistance and post-prandial hyperglycemia, adult patients with hepatic steatosis that does not respond to weight loss are placed on insulin sensitizing drugs. We hypothesize that weight loss with a diet designed to decrease insulin resistance and post-prandial hyperglycemia, a low glycemic load diet, will provide a safe and effective way to decrease hepatic fat content in the pediatric population. This hypothesis will be tested with a randomized control trial comparing the effect of a low fat diet with a low glycemic load diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >95th percentile for age and sex
- •Weight <300 pounds
- •Ability to lie quietly in the MRI for approximately 45 minutes
- •Willing and able to attend all sessions.
- •Working telephone
- •Greater than or equal to 10% hepatic steatosis on nMR spectroscopy
排除标准
- •Any other medical condition besides obesity that may predispose to liver disease
- •Medications that affect liver metabolism
- •Any causes of chronic hepatitis
- •Inability to adhere to prescribed diets
- •Currently on high-dose vitamins and not willing to discontinue
- •Weight loss/gain in the past 6 months of >10% of total body weight.
- •Sibling of any subject who is already enrolled
- •Any alcohol consumption
结局指标
主要结局
percent liver fat as determined by nMR spectroscopy
时间窗: 6 months
次要结局
- hepatic steatosis as measured by T1 weighted MRI images(6 monhts)
- visceral fat(6 months)
- liver function tests(6 months)
- measures of oxidative stress(6 months)
- measures of chronic inflammation(6 months)
- insulin resistance(6 months)
- serum lipids(6 months)
- blood pressure(6 months)
- insulin secretion(baseline)
- measures of glucose tolerance(6 months)
- adiponectin(6 months)
