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New study aims to catch hidden liver disease in diabetes patients

NCT ID NCT07270822

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test a two-step screening program for advanced liver fibrosis in people with type 2 diabetes. About 1,714 patients will first get a blood test (FIB-4), and if that suggests risk, they will receive a liver stiffness measurement (transient elastography). The goal is to see if this systematic approach helps more patients get diagnosed and referred to specialists, compared to current practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could establish a practical screening pathway that catches liver fibrosis earlier in people with type 2 diabetes, potentially reducing liver-related complications.
What could go wrong
This is an implementation study, not a treatment trial. It tests whether a screening process works in real-world clinics, not whether it improves health outcomes directly. Success depends on clinic participation and follow-through.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,714 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patient, male or female * Type 2 diabetic patient, followed by a diabetologist in private practice participating in the study * Patient affiliated to a French or European healthcare insurance * Patient who agrees to be included in the study and who signs the informed consent form Exclusion Criteria: * Evidence of advanced fibrosis (F3 or F4 fibrosis based on the results from previous liver biopsy F3 ou F4 or evidence of cirrhosis). * Evidence of other causes of chronic liver disease * Patient who does not understand French/ is unable to give consent, * Patient already included in a trial who may interfere with the study * The subject is a pregnant or nursing female * Minor patient * Patient deprived of liberty, * Patient admitted to a health or social establishment for purposes other than research * Mentally unbalanced patients, under supervision or guardianship, * Patient undergoing psychiatric care * Patient not affiliated to a healthcare insurance plan * Patient already included in this screening program in the previous 12 months

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Conditions

The condition(s) this trial relates to.

alcoholic fatty liver disease cirrhosis of liver fatty liver disease fibrotic liver disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibrosis of liver Steatotic liver disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Diabetology private center

    Caluire-et-Cuire, 69300, France

  • Diabetology private center

    Lyon, 69001, France

  • Diabetology private center

    Lyon, 69001, France

  • Diabetology private center

    Lyon, 69002, France

  • Diabetology private center

    Lyon, 69005, France

  • Diabetology private center

    Lyon, 69009, France

  • Diabetology private center

    Lyon, 69009, France

  • Diabetology private center

    Lyon, 69009, France

  • Diabetology private center

    Saint-Maurice-l'Exil, 38550, France

  • Diabetology private center

    Sathonay-Camp, 69580, France

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