NCT03432377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

January 24, 2018

Last Update Submit

January 27, 2021

Conditions

Non Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • 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

  • 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

  • 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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Non-Alcoholic Steatohepatitis

You may qualify if:

  • 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)

You may not qualify if:

  • Age \<18 years
  • Viral hepatitis and other chronic liver diseases
  • Alcohol consumption\> 20g / day for women, 30g / day for men
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Centre Hospitalier de Béziers

Béziers, 34500, France

Location

Centre hospitalier Métropole Savoie

Chambéry, 73011, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

Groupe Hospitalier Public Sud Oise

Creil, 60100, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

Location

Centre Hospitalier de Gonesse

Gonesse, 95500, France

Location

Centre Hospitalier de Hyères

Hyères, 83400, France

Location

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier de Bretagne Sud

Lorient, 56322, France

Location

Hôpital de Melun

Melun, 77011, France

Location

Centre hospitalier Annecy Genevois

Metz-Tessy, 74370, France

Location

Centre hospitalier Montelimar

Montélimar, 26200, France

Location

Hôpital de Diaconesses

Paris, 75012, France

Location

Centre Hospitalier de Perpignan

Perpignan, 66000, France

Location

Centre Hospitalier de Saint Denis

Saint-Denis, 93200, France

Location

Centre Hospitalier de Sens

Sens, 89100, France

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Hugues BLONDON, Department head

    Versailles Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Hepatogastroenterology Service

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 14, 2018

Study Start

November 15, 2017

Primary Completion

November 17, 2020

Study Completion

November 17, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

FR(16)