Clinical trial NCT06738810: : 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Steato-hepatitis
Keywords: NASH,
type 2 diabetes mellitus
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There will be a single group. Indeed, all type 2 diabetes with or without a hepatic check-up will be included in the study.
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: fibrotest-Actitest
timeFrame: 24 hours
measure: NASH test
timeFrame: 24 hours
measure: NAFDL fibrosis score
timeFrame: 24 hours
Secondary outcomes:
measure: : hepatic ultrasound,
timeFrame: 24 hours
measure: Standard liver test
timeFrame: 24 hours
measure: Lipid balance
timeFrame: 24 hours
measure: Lipid balance
timeFrame: 24 hours
measure: Lipid balance
timeFrame: 24 hours
measure: Assessment to eliminate other causes of chronic disease
timeFrame: 24 hours
measure: Assessment to eliminate other causes of chronic disease
timeFrame: 24 hours
measure: Assessment to eliminate other causes of chronic disease
timeFrame: 24 hours
measure: Assessment to eliminate other causes of chronic disease
timeFrame: 24 hours
measure: Platelets
timeFrame: 24 hours
Other outcomes:
Locations:
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU de la Guadeloupe
Study officials:
References: