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临床试验/NCT02670590
NCT02670590已完成不适用

NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele0 个研究点目标入组 150 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
主要终点
Decrease of fatty liver appearance by ultrasound

研究概览

简要总结

Investigators perform a counseling intervention study (6 months) in adult subjects with evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS); exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate < 90 ml/min), cancer, heart failure > II NYHA ( New York Heart Association) Class), chronic virus hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual "healthy" food purchase, storage, and cooking were given. Reliable feedback and evidence of patients' adherence were obtained by scheduled dietician's interviews. Investigators will challenge the predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score and of increased physical activity at 6 months in a body mass index changes-balanced model to detect independent effects, if any, of the studied variable on NAFLD persistence, amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary profile score will be calculated by contingency tables and receiver operator characteristic curve (ROC) analysis..

详细描述

Dietary and physical exercise counseling.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical diagnosis of fatty liver

排除标准

  • type I or type II diabetes,
  • no alcohol, cancer, malnutrition, severe obesity, renal insufficiency, viral hepatitis, other chronic disease

结局指标

主要结局

Decrease of fatty liver appearance by ultrasound

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guglielmo Trovato, MD, PhD

Dirigente Medico

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

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