Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01101-52 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| type 2 diabetes with a hepatic check-up patients | Other | For the study, a blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrotest-actitest/NASHtest | Diagnostic Test | A blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest and to calculate the NAFLD fibrosis score |
| Measure | Description | Time Frame |
|---|---|---|
| fibrotest-Actitest | 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. | 24 hours |
| NASH test | 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 | 24 hours |
| NAFDL fibrosis score | 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:
| 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| : hepatic ultrasound, | 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. | 24 hours |
| Standard liver test |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de la Guadeloupe | Pointe-Ã -Pitre | Pointe-Ã -Pitre | 97159 | Guadeloupe |
Any plan has been do
Not provided
Not provided
Not provided
Not provided
Not provided
There will be a single group. Indeed, all type 2 diabetes with or without a hepatic check-up will be included in the study.
Not provided
Not provided
Not provided
Not provided
|
Blood analysis for liver function assessment (ASAT, ALAT, gGT, PAL) |
| 24 hours |
| Lipid balance | Blood analysis for lipid metabolism assessment (total cholesterol, HDL cholesterol, triglycerides), which constitutes an important risk factor for cardiovascular disease | 24 hours |
| Lipid balance | HDL | 24 hours |
| Lipid balance | triglyceride | 24 hours |
| Assessment to eliminate other causes of chronic disease | HBV and HCV serologies for viral hepatitis | 24 hours |
| Assessment to eliminate other causes of chronic disease | auto-immune antibodies for auto-immune hepatitis | 24 hours |
| Assessment to eliminate other causes of chronic disease | ferritinemia and saturation coefficient of transferin for hemochromatosis | 24 hours |
| Assessment to eliminate other causes of chronic disease | carboxy deficient transferin for alcoholism | 24 hours |
| Platelets | Platelet | 24 hours |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided