Non-alcoholic Steato-hepatitis
Conditions
Keywords
NASH,, type 2 diabetes mellitus
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.
Interventions
DIAGNOSTIC_TESTFibrotest-actitest/NASHtest
A blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest and to calculate the NAFLD fibrosis score
Sponsors
Centre Hospitalier Universitaire de la Guadeloupe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment to eliminate other causes of chronic disease | 24 hours | HBV and HCV serologies for viral hepatitis |
| : 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. |
| Platelets | 24 hours | Platelet |
| Standard liver test | 24 hours | Blood analysis for liver function assessment (ASAT, ALAT, gGT, PAL) |
| Lipid balance | 24 hours | Blood analysis for lipid metabolism assessment (total cholesterol, HDL cholesterol, triglycerides), which constitutes an important risk factor for cardiovascular disease |
Countries
Guadeloupe
Outcome results
None listed