Screening of Liver Fibrosis Using Blood Tests in Patients With Type 2 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

722 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-25

Study Completion Date

2025-06-27

Brief Summary

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Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic SteatoHepatitis (NASH), are a frequent complication of type 2 diabetes and obesity. This disease has been linked with an increased morbidity and mortality, in particular cardiovascular disease and hepatic complications (cirrhosis and hepatocellular carcinoma). NAFLD is covered different liver damage in ascending order: steatosis, Non-Alcoholic SteatoHepatitis (NASH), fibrosis, and finally cirrhosis. Mostly, fibrosis has a determining role in the patient's status health. The fibrosis prevalence rate may reach up to 15 % of people with type 2 diabetes. The purpose of the study is to screen hepatic fibrosis for patient with type 2 diabetes.

To be sure of the status of the disease, the gold standard procedure remains liver biopsy. However, it's an invasive procedure and it's a challenge to perform this kind of medical procedure to every patient with NAFLD. Some alternative procedure exists, called FibroScan that gives some indication of liver fibrosis status. Unfortunately, every diabetologist hasn't this equipment in his medical office. The investigators propose to evaluate two non-invasive biological fibrosis tests, called eLIFT and FibroMeter. The results of these two diagnostic tests will be compared to FibroScan and to liver biopsy results.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 NAFLD NASH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood tests

Two diagnostic tests (eLift and FibroMeter) will be performed to evaluate liver fibrosis

Group Type EXPERIMENTAL

Blood tests

Intervention Type DIAGNOSTIC_TEST

eLift and FibroMeter

Interventions

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Blood tests

eLift and FibroMeter

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 40 years old,
* Type 2 diabetes mellitus for more than 6 months,
* BMI \> 25 kg/m2,
* Waist circumference \> 94 cm (male) or 80 cm (female).
* Patient benefiting from a social security system.

Exclusion Criteria

* Medical follow up for liver disease,
* Decompensated cirrhosis,
* Health status that does not allow the participation of the patient,
* Hospitalisation for acute complication: sepsis, infection, foot's ulcer, acute coronary syndrome,…
* HbA1c \> 11,0 %,
* Pregnancy.
* Patient under guardianship or curatorship or protection of justice
* Involvement refusal.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No