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COCANASH: Coffee Consumption and NASH in the French Population.

Sponsor
Versailles Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03432377
Collaborator
(none)
107
Enrollment
16
Locations
36.1
Actual Duration (Months)
6.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    107 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Coffee Consumption and NASH in the French Population.
    Actual Study Start Date :
    Nov 15, 2017
    Actual Primary Completion Date :
    Nov 17, 2020
    Actual Study Completion Date :
    Nov 17, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. 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]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 Centre Hospitalier Intercommunal de Créteil Créteil France 94010
    6 Centre Hospitalier de Gonesse Gonesse France 95500
    7 Centre Hospitalier de Hyères Hyères France 83400
    8 Centre Hospitalier Départemental Vendée La Roche-sur-Yon France 85925
    9 Centre Hospitalier de Bretagne Sud Lorient France 56322
    10 Hôpital de Melun Melun France 77011
    11 Centre hospitalier Annecy Genevois Metz-Tessy France 74370
    12 Centre hospitalier Montelimar Montélimar France 26200
    13 Hôpital de Diaconesses Paris France 75012
    14 Centre Hospitalier de Perpignan Perpignan France 66000
    15 Centre Hospitalier de Saint Denis Saint-Denis France 93200
    16 Centre Hospitalier de Sens Sens France 89100

    Sponsors and Collaborators

    • Versailles Hospital

    Investigators

    • Principal Investigator: Hugues BLONDON, Department head, Versailles Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Hugues Blondon, Head of Hepatogastroenterology Service, Versailles Hospital
    ClinicalTrials.gov Identifier:
    NCT03432377
    Other Study ID Numbers:
    • P16/17_COCANASH
    • 2016-A01872-49
    First Posted:
    Feb 14, 2018
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fatty Liver
    Non-alcoholic Fatty Liver Disease

    Study Results

    No Results Posted as of Jan 28, 2021