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Status:

COMPLETED

Coffee Consumption and NASH in the French Population.

Lead Sponsor:

Versailles Hospital

Conditions:

Non Alcoholic Steatohepatitis

Eligibility:

All Genders

18+ years

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 15 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 17 2020

Estimated Enrollment :

107 Patients enrolled

Trial Details

Trial ID

NCT03432377

Start Date

November 15 2017

End Date

November 17 2020

Last Update

January 28 2021

Active Locations (16)

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Page 1 of 4 (16 locations)

1

Centre Hospitalier de Béziers

Béziers, France, 34500

2

Centre hospitalier Métropole Savoie

Chambéry, France, 73011

3

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100

4

Groupe Hospitalier Public Sud Oise

Creil, France, 60100