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NCT Number: 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

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

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Key information

Conditions

Non-alcoholic Steato-hepatitis Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de la Guadeloupe

Pointe-à-Pitre, 97159, Guadeloupe

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: NAFLD fibrosis score

Primary outcomes

  1. fibrotest-Actitest

    Time frame: 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.

  2. NASH test

    Time frame: 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

  3. NAFDL fibrosis score

    Time frame: 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 outcomes

  1. : hepatic ultrasound,

    Time frame: 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.

  2. Standard liver test

    Time frame: 24 hours

    Blood analysis for liver function assessment (ASAT, ALAT, gGT, PAL)

  3. Lipid balance

    Time frame: 24 hours

    Blood analysis for lipid metabolism assessment (total cholesterol, HDL cholesterol, triglycerides), which constitutes an important risk factor for cardiovascular disease

  4. Lipid balance

    Time frame: 24 hours

    HDL

  5. Lipid balance

    Time frame: 24 hours

    triglyceride

  6. Assessment to eliminate other causes of chronic disease

    Time frame: 24 hours

    HBV and HCV serologies for viral hepatitis

  7. Assessment to eliminate other causes of chronic disease

    Time frame: 24 hours

    auto-immune antibodies for auto-immune hepatitis

  8. Assessment to eliminate other causes of chronic disease

    Time frame: 24 hours

    ferritinemia and saturation coefficient of transferin for hemochromatosis

  9. Assessment to eliminate other causes of chronic disease

    Time frame: 24 hours

    carboxy deficient transferin for alcoholism

  10. Platelets

    Time frame: 24 hours

    Platelet

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Other

Registry information

Official study 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

Acronym: STEATOGWAD

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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