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临床试验/NCT00480922
NCT00480922已完成不适用

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

Boston Children's Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2007年5月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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