Non Alcoholic SteatohepatitisCOCANASHNCT03432377
Coffee Consumption and NASH in the French Population.
An observational study of Non Alcoholic Steatohepatitis, run by Versailles Hospital at 16 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Alcoholic Steatohepatitis
- How many people
- 107 participants
- Where
- 16 sitesFrance
- Study dates
- 15 Nov 2017to 17 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-Alcoholic Steatohepatitis
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 9Show fewer
- 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 locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Centre Hospitalier de Béziers
Béziers, 34500
Centre hospitalier Métropole Savoie
Chambéry, 73011
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
Groupe Hospitalier Public Sud Oise
Creil, 60100
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Centre Hospitalier de Gonesse
Gonesse, 95500
Centre Hospitalier de Hyères
Hyères, 83400
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85925
Centre Hospitalier de Bretagne Sud
Lorient, 56322
Hôpital de Melun
Melun, 77011
Centre hospitalier Annecy Genevois
Metz-Tessy, 74370
Centre hospitalier Montelimar
Montélimar, 26200
Hôpital de Diaconesses
Paris, 75012
Centre Hospitalier de Perpignan
Perpignan, 66000
Centre Hospitalier de Saint Denis
Saint-Denis, 93200
Centre Hospitalier de Sens
Sens, 89100
About this study
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.
- Conditions
- Non Alcoholic Steatohepatitis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start15 Nov 2017
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Hugues Blondon, Versailles Hospital
- Investigators
- Hugues BLONDON, Department head, Principal investigator, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432377
- Sponsor's protocol ID
- P16/17_COCANASH
- Other IDs
- 2016-A01872-49
- Acronym
- COCANASH
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2018
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coffee Consumption and NASH in the French Population.
- ClinicalTrials.gov ID
- NCT03432377
- Acronym / sponsor ID
- COCANASH / P16/17_COCANASH
- Conditions
- Non Alcoholic Steatohepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-Alcoholic Steatohepatitis
Key inclusion criteria (8 listed)
- Any newly diagnosed case of NASH histologically proven graded according to SAF criteria
- waist size> 94cm (men) or> 80cm (women)
- and the presence of at least two of the following criteria:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Day 0
3 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugues BLONDON, Department head principal investigator
Versailles Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Alcoholic Steatohepatitis, run by Versailles Hospital at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.