Simple blood tests could spot liver damage early in diabetics
NCT ID NCT06567990
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study is testing whether simple blood tests and a liver scan can accurately track liver disease progression in 500 people with type 2 diabetes. Participants will be followed over time to see if these non-invasive tools can replace liver biopsies for detecting advanced scarring. The goal is to make screening easier and catch serious liver problems earlier.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Non-invasive blood tests and imaging (FibroScan)
- What this could lead to
- If successful, this could lead to better, simpler ways to detect liver disease progression early in people with type 2 diabetes, potentially preventing severe complications.
- What could go wrong
- This is an observational study, not a treatment trial. The biomarkers may not prove accurate enough to change clinical practice, and results may take years to confirm.
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
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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
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with T2D and meeting the other inclusion criteria of the NAFLD-Care study: * Patient aged between 40 and 80 years old, * Patient with hepatic steatosis determined by conventional abdominal ultrasound as defined by the EASL/EASO/EASD European guidelines. * Patient who agrees to be included in the study and who signs the informed consent form, * Patient affiliated to a healthcare insurance plan. Exclusion Criteria: \- Participants with a diagnosis of cirrhosis defined by a liver biopsy with histological stage of fibrosis F4 or a proven diagnosis of cirrhosis by magnetic resonance imaging. The main non-inclusion criteria for the NAFLD-CARE study are: * Evidence of other causes of chronic liver disease : 1. Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg). 2. Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Ab in serum (anti-HCV Ab). 3. Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy. 4. Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis. 5. Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease. 6. Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency. 7. Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D. 8. Drug-induced liver disease as defined on the basis of typical exposure and history. 9. Bile duct obstruction as shown by imaging studies. * History of ingestion of medications known to produce steatosis in the previous 6 months. * Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices * Presence of regular and/or excessive use of alcohol (defined as \>30g/day for males and \>15g/day for females) for a period longer than 2 years at any times in the last 10 years * The subject is a pregnant or nursing female * Life expectancy less than 5 years * History of known HIV infection * History of type 1 diabetes * BMI ≥ 45 kg/m2 * Mentally unbalanced patients, under supervision or guardianship, * Patient deprived of liberty, * Patient who does not understand French/ is unable to give consent, * Patient already included in a trial who may interfere with the study or in a period of exclusion following participation in a previous study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Clinique d'Endocrinologie, Maladies Métaboliques et Nutrition CIC Endocrino-Nut
RECRUITINGNantes, 44093, France
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Endocrinologie, Diabète et Nutrition in Louis PRADEL Hospital
RECRUITINGLyon, 69677, France
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Service Endocrinologie, Diabétologie, Maladies Métaboliques et Nutrition
RECRUITINGDijon, BP 1542- 14, France
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Service d'Endocrinologie, Diabète et nutrition
RECRUITINGPierre-Bénite, 69495, France
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