NCT03432377已完成不适用
Coffee Consumption and NASH in the French Population.
Versailles Hospital16 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2017年11月15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
- 107
- 试验地点
- 16
- 主要终点
- To compare coffee caffeine consumption in NASH patients with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors.
研究概览
简要总结
The aim of our study is to evaluate the effect of coffee consumption on the risk of severe liver fibrosis in French patients with NASH.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any newly diagnosed case of NASH histologically proven graded according to SAF criteria
- •Or Metabolic syndrome defined by the IDF 2005 criteria:
- •waist size> 94cm (men) or> 80cm (women)
- •and the presence of at least two of the following criteria:
- •blood pressure: Systolic ≥ 130mmHg OR diastolic ≥ 85 mmHg OR antihypertensive treatment
- •Triglycerides ≥ 1.5g / L or lipid-lowering therapy
- •HDL cholesterol <0.4 g / L (men) or <0.5 g / L (women) or lipid-lowering therapy
- •fasting blood glucose:> 1 g / L or type 2 diabetes AND Hepatic steatosis diagnosed on liver imaging And liver fibrosis (diagnosed with a FibroScan> 6 KPa)
排除标准
- •Age <18 years
- •Viral hepatitis and other chronic liver diseases
- •Alcohol consumption> 20g / day for women, 30g / day for men
- •Liver biopsy or FibroScan dating more than 6 months before inclusion.
- •History of bariatric surgery
- •Serious psychiatric pathology (psychosis, dementia, severe depression) and patients under legal protection (tutelage, guardianship)
- •Solid cancer or progressive hematology or <2 years (except basal cell carcinoma or localized squamous cell carcinoma)
- •Severe and terminal chronic renal insufficiency (estimated GFR <30mL / min)
- •Recent myocardial infarction <6 months
结局指标
主要结局
To compare coffee caffeine consumption in NASH patients with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors.
时间窗: Day 0
次要结局
- Comparison of total caffeine consumption from all types of drinks in patients with NASH with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors.(Day 0)
- Evaluation of the correlation between the degree of hepatic fibrosis assessed by elastometry (FibroScan) or the histological stage and the caffeine consumption from coffee in univariate analysis and after adjustment for potential confounding factors.(Day 0)
- Comparison of the percentage of regular coffee drinkers in NASH patients with early (F1-2) vs advanced (F3-4) liver fibrosis in univariate analysis and after adjustment for potential confounding factors.(Day 0)
研究者
Dr Hugues Blondon
Head of Hepatogastroenterology Service
Versailles Hospital
研究点 (16)
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