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: 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

NCT ID: NCT06738810

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-21

Study Completion Date

2022-02-01

Brief Summary

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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

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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.

Conditions

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Non-alcoholic Steato-hepatitis

Keywords

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NASH, type 2 diabetes mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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type 2 diabetes with a hepatic check-up patients

For the study, a blood sample will be collected from the patient in order to do Fibrotest-actitest/NASHtest.

Group Type OTHER

Fibrotest-actitest/NASHtest

Intervention Type 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

Interventions

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Fibrotest-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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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NAFLD fibrosis score

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de la Guadeloupe

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

Site Status

Countries

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Guadeloupe

Other Identifiers

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2017-A01101-52

Identifier Type: OTHER

Identifier Source: secondary_id

PAP_RI2_2017/06

Identifier Type: -

Identifier Source: org_study_id