Clinical trial NCT03432377: Coffee Consumption and NASH in the French Population.
Official title: Coffee Consumption and NASH in the French Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-Alcoholic Steatohepatitis

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 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

Primary outcomes:
measure: 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.
timeFrame: Day 0
Secondary outcomes:
measure: 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.
timeFrame: Day 0
measure: 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.
timeFrame: Day 0
measure: 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.
timeFrame: Day 0
Other outcomes:
Locations:
city: Béziers
country: France
facility: Centre Hospitalier de Béziers
city: Chambéry
country: France
facility: Centre hospitalier Métropole Savoie
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Creil
country: France
facility: Groupe Hospitalier Public Sud Oise
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Gonesse
country: France
facility: Centre Hospitalier de Gonesse
city: Hyères
country: France
facility: Centre Hospitalier de Hyères
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental Vendée
city: Lorient
country: France
facility: Centre Hospitalier de Bretagne Sud
city: Melun
country: France
facility: Hôpital de Melun
city: Metz-Tessy
country: France
facility: Centre hospitalier Annecy Genevois
city: Montélimar
country: France
facility: Centre hospitalier Montelimar
city: Paris
country: France
facility: Hôpital de Diaconesses
city: Perpignan
country: France
facility: Centre Hospitalier de Perpignan
city: Saint-Denis
country: France
facility: Centre Hospitalier de Saint Denis
city: Sens
country: France
facility: Centre Hospitalier de Sens
Study officials:
affiliation: Versailles Hospital
name: Hugues BLONDON, Department head
role: PRINCIPAL_INVESTIGATOR
References: