Coffee Consumption and NASH in the French Population.

Completed

• Conditions: Non Alcoholic Steatohepatitis

• Registration Number: NCT03432377
• Lead Sponsor: Versailles Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-15
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-14
• Primary Completion: 2020-11-17
• Study Completion: 2020-11-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

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)

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Day 0

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (16)

Hôpital de Diaconesses; 🇫🇷 Paris, France

Groupe Hospitalier Public Sud Oise; 🇫🇷 Creil, France

Hôpital de Melun; 🇫🇷 Melun, France

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

Centre Hospitalier de Bretagne Sud; 🇫🇷 Lorient, France

Centre Hospitalier de Béziers; 🇫🇷 Béziers, France

Centre hospitalier Métropole Savoie; 🇫🇷 Chambéry, France

Centre Hospitalier de Gonesse; 🇫🇷 Gonesse, France

Centre Hospitalier de Sens; 🇫🇷 Sens, France

Centre Hospitalier Intercommunal de Créteil; 🇫🇷 Créteil, France

Centre Hospitalier de Hyères; 🇫🇷 Hyères, France

Centre Hospitalier Départemental Vendée; 🇫🇷 La Roche-sur-Yon, France

Centre hospitalier Annecy Genevois; 🇫🇷 Metz-Tessy, France

Centre hospitalier Montelimar; 🇫🇷 Montélimar, France

Centre Hospitalier de Perpignan; 🇫🇷 Perpignan, France

Centre Hospitalier de Saint Denis; 🇫🇷 Saint-Denis, France