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Coffee Consumption and NASH in the French Population. (COCANASH)

V

Versailles Hospital

Status

Completed

Conditions

Non Alcoholic Steatohepatitis

Study type

Observational

Funder types

Other

Identifiers

NCT03432377
P16/17_COCANASH
2016-A01872-49 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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