: 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

Not Applicable

Completed

• Conditions: Non-alcoholic Steato-hepatitis

• Registration Number: NCT06738810
• Lead Sponsor: Centre Hospitalier Universitaire de Pointe-a-Pitre

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.

Study Timeline

• Study Start: 2018-06-21
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
fibrotest-Actitest	24 hours	Fibrotest-actitest uses the biological analysis of alpha 2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, gGT, ALAT, ASAT, fasting blood glucose, cholesterol, triglycerides. A fibrotest score \>0.48 is suggestive of advanced liver fibrosis.
NASH test	24 hours	NASHtest uses the biological analysis of alpha 2 macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, gGT, ALAT, ASAT, fasting blood glucose, cholesterol, triglycerides. NASHtest interpretation: NashTest 2 score Grade Interpretation; 0.00-0.25\* N0 No NASH; 0.25-0.50\* N1 Mild NASH; 0.50-0.75\* N2 Moderate NASH; 0.75-1.00\* N3 Severe NASH
NAFDL fibrosis score	24 hours	Non-Alcoholic Fatty Liver Disease (NAFLD) fibrosis score estimates amount of scarring in the liver based on age and body mass index of the patient, and several laboratory tests as ASAT, ALAT, platelet count and albumin. NAFLD fibrosis score can be interpretate as below: * less than -1.455: low probability of fibrosis; * from -1.445 to 0.676 : intermediate score; * more than 0.676: high probability of fibrosis

Secondary Outcome Measures

Name	Time	Method
Assessment to eliminate other causes of chronic disease	24 hours	carboxy deficient transferin for alcoholism
Platelets	24 hours	Platelet
Standard liver test	24 hours	Blood analysis for liver function assessment (ASAT, ALAT, gGT, PAL)
Lipid balance	24 hours	triglyceride
: hepatic ultrasound,	24 hours	Patients will be assessed by liver ultrasound which is a non invasive test that produces images of liver and its blood vessels. It's a valuable diagnostic tool for assessing liver anatomy, size and pathology as cirrhosis or liver steatosis.

Trial Locations

Locations (1)

CHU de la Guadeloupe; 🇬🇵 Pointe-à-Pitre, Guadeloupe