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NCT03432377 Clinical Trial

Coffee Consumption and NASH in the French Population.

Non Alcoholic Steatohepatitis Clinical Trial

— COCANASH  

Official title:
Coffee Consumption and NASH in the French Population.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03432377
Other study ID # P16/17_COCANASH
Secondary ID 2016-A01872-49
Status Completed
Phase
First received
Last updated
Start date November 15, 2017
Est. completion date November 17, 2020

Study information
Verified date January 2021
Source Versailles Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 107
Est. completion date November 17, 2020
Est. primary completion date November 17, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier de Béziers Béziers
France Centre hospitalier Métropole Savoie Chambéry
France Centre Hospitalier Sud Francilien Corbeil-Essonnes
France Groupe Hospitalier Public Sud Oise Creil
France Centre Hospitalier Intercommunal de Créteil Créteil
France Centre Hospitalier de Gonesse Gonesse
France Centre Hospitalier de Hyères Hyères
France Centre Hospitalier Départemental Vendée La Roche-sur-Yon
France Centre Hospitalier de Bretagne Sud Lorient
France Hôpital de Melun Melun
France Centre hospitalier Annecy Genevois Metz-Tessy
France Centre hospitalier Montelimar Montélimar
France Hôpital de Diaconesses Paris
France Centre Hospitalier de Perpignan Perpignan
France Centre Hospitalier de Saint Denis Saint-Denis
France Centre Hospitalier de Sens Sens

Sponsors (1)
Lead Sponsor Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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