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NAC- NAFLD and Cushing

NCT ID: NCT05881005

Last Updated: 2024-12-16

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2027-09-28

Brief Summary

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Cushing's Syndrome is a rare disease resulting from prolonged exposure to high levels of circulating cortisol. Clinical manifestations are variable but many patients present a metabolic syndrome (abdominal obesity, insulin resistance, dyslipidemia, hypertension). With regard to the liver, experimental data have shown that excess cortisol leads in an increase in lipogenesis and a reduction in the oxidation of fatty acids. This, in association with an accumulation of visceral adipose tissue and deregulation of adipokines, may contribute to the development of hepatic steatosis in animals. However, few data is available in humans with only one study of 50 patients with Cushing's syndrome estimating the prevalence of hepatic steatosis at 20%.

NAFLD (Non-Alcoholic Fatty Liver Disease), is defined as the presence of hepatic steatosis in the absence of secondary causes of intrahepatic fat accumulation. It is a heterogeneous disease ranging from simple liver steatosis, whose prognosis is generally considered to be benign, to inflammation (NASH, Non-Alcoholic Steato-Hepatitis) which may progress to fibrosis, cirrhosis and an increased risk of hepatocellular carcinoma. The prognosis for NAFLD is mainly related to the severity of hepatic fibrosis.

In Cushing's syndrome, normalization of cortisol production is the most effective strategy to improve co-morbidities associated with hypercortisolism. However, some of these complications, especially the metabolic co morbidities, could not be completely reversible and no data is available about resolution of hepatic steatosis.

Detailed Description

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Conditions

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Cushing Syndrome Fatty Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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open-label study

hepatic MRI, Fibroscan

Group Type OTHER

hepatic MRI

Intervention Type DIAGNOSTIC_TEST

Quantification of hepatic steatosis with RMI at the diagnosis (T0) and one year after remission (T1). The percentage of patients with complete resolution of hepatic steatosis on MRI will be determined.

Interventions

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hepatic MRI

Quantification of hepatic steatosis with RMI at the diagnosis (T0) and one year after remission (T1). The percentage of patients with complete resolution of hepatic steatosis on MRI will be determined.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Fibroscan

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Active Cushing's syndrome

Exclusion Criteria

* Other common causes of chronic liver disease (HBV, HCV, haemochromatosis, alcohol)
* Contraindication to MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire BRIET

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Anger

Locations

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University Hospital, Angers

Angers, , France

Site Status RECRUITING

University Hospital, Bordeaux

Bordeaux, , France

Site Status RECRUITING

University Hospital, Brest

Brest, , France

Site Status RECRUITING

University Hospital, Grenoble

Grenoble, , France

Site Status RECRUITING

University Hospital, Nantes

Nantes, , France

Site Status RECRUITING

University Hospital, Rennes

Rennes, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Claire BRIET

Role: CONTACT

Phone: 02 41 35 36 37

Email: [email protected]

Facility Contacts

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Claire BRIET, MD

Role: primary

Amandine FERRIERE, PHD

Role: primary

PHILIPPE TUILLIER, MD

Role: primary

JUSTINE CRISTANTE, PHD

Role: primary

Sarra SMATI GRANGEON, PHD

Role: primary

ANNABELLE ESVANT, PHD

Role: primary

Other Identifiers

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2023-A00727-38

Identifier Type: OTHER

Identifier Source: secondary_id

49RC22-0389

Identifier Type: -

Identifier Source: org_study_id