: 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

NCT06738810 | Completed

• 2 other identifiers: PAP_RI2_2017/062017-A01101-52
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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

Conditions

Non-alcoholic Steato-hepatitis

Keywords

NASH,; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (3)

• 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: * less than -1.455: low probability of fibrosis * from -1.445 to 0.676 : intermediate score * more than 0.676: high probability of fibrosis

  24 hours

Secondary Outcomes (10)

• : hepatic ultrasound,

  24 hours

• Standard liver test

  24 hours

• Lipid balance

  24 hours

• Lipid balance

  24 hours

• Lipid balance

  24 hours

Study Arms (1)

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.

Diagnostic Test: Fibrotest-actitest/NASHtest

Interventions

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

Also known as: NAFLD fibrosis score

type 2 diabetes with a hepatic check-up patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus patient with impaired hepatic function (transaminases and / or PAL and / or gamma-GT\> Norm)
• Age ≥18 years
• Affiliate or beneficiary of a social security scheme.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

CHU de la Guadeloupe

Pointe-à-Pitre, Pointe-à-Pitre, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There will be a single group. Indeed, all type 2 diabetes with or without a hepatic check-up will be included in the study.

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: December 18, 2024
• Study Start: June 21, 2018
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 18, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1)