: Identification of Non-alcoholic Steato-hepatitis Cases in a Sample of Type 2 Diabetes Patients, with a Disruption of the Liver Function Tests, At the Pointe-à-Pitre University Hospital (STEATOGWAD)

Centre Hospitalier Universitaire de la Guadeloupe

Status: Completed

Conditions: Non-alcoholic Steato-hepatitis

Treatments: Diagnostic Test: Fibrotest-actitest/NASHtest

Study type: Interventional

Funder types: Other

Identifiers

NCT06738810

PAP_RI2_2017/06

2017-A01101-52 (Other Identifier)

Details and patient eligibility

About

Non-alcoholic steatohepatitis (NASH) develops on insulin resistance, especially in patients with carbohydrate tolerance. NASH may progress to more extensive fibrosis, including cirrhosis, but also to HCC with or without cirrhosis in 10 to 20% of cases. The main objective of our research is to identify the prevalence of NASH in a sample of 100 patients with type 2 diabetes mellitus (T2DM), consulting in the PAP hospital and having a liver function disorder

Full description

In Guadeloupe, the prevalence of T2DM is estimated to be 20%, among the highest in the French departements. NASH is probably present in our patients with T2DM but we do not know its prevalence. There is no data on the development of NASH in the Afro-Caribbean population, but in the United States, it has been observed that NASH was less prevalent among African-Americans compared to Caucasian and Hispanic Americans, and this could be explained by differences genetics in fat metabolism. In view of the emergence of NASH worldwide as a cause of chronic liver disease, it is necessary to carry out a pilot study to determine the presence or absence of NASH in T2DM patients in Guadeloupe. This will necessitate a systematic evaluation of liver function, usually performed during the T2DM assessment but not necessarily followed by specialized advice to confirm or invalidate the diagnosis of NASH. For each patient, an abnormality of liver function will be assessed by usual serum tests (transaminases, GGT, PAL). Prescription for a fibrotest / actitest + NASHtest and the NAFLD fibrosis score, will be perfomred as well as ultrasound and blood tests to eliminate other causes of liver disease (viral B or C, alcoholic, autoimmune, hemochromatosis) will also be performed.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus patient with impaired hepatic function (transaminases and / or PAL and / or gamma-GT> Norm)
• Age ≥18 years
• Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
• Affiliate or beneficiary of a social security scheme.

Exclusion criteria

• Pregnancy or breast-feeding
• No diabetes or type 1 diabetes
• Chronic hepatopathy of other origin: viral B, C, alcohol, hemochromatosis, α1-antitrypsin deficiency, Wilson's disease, autoimmune hepatitis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

type 2 diabetes with a hepatic check-up patients

Other group

Description:

For the study, a blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest.

Treatment:

Diagnostic Test: Fibrotest-actitest/NASHtest