NAC- NAFLD And Cushing

Study Overview
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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.

Official Title
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Prévalence de la stéato-fibrose hépatique Dans le Syndrome de Cushing

Conditions
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Cushing Syndrome, Fatty Liver Disease

Intervention / Treatment
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* Diagnostic Test: hepatic MRI


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: open-label study<br>hepatic MRI, Fibroscan | Diagnostic Test: hepatic MRI<br>* 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.<br>* Other names: Fibroscan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of resolution of hepatic steatosis | To evaluate the frequency of complete resolution of hepatic steatosis in patients with cushing syndrome after remission of hypercortisolism | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of steatosis at diagnosis of Cushing | to assess the prevalence of hepatic steatosis at the diagnosis of Cushing's syndrome. | 2 years | 
| Prevalence of steatosis at diagnosis of Cushing | to evaluate the prevalence of steatosis | 2 years | 
| Fatty Liver Index (non-invasive biomarkers of hepatic steatosis ) | to evaluate the non-invasive biomarkers of hepatic steatosis (Fatty Liver Index) | 2 years | 
| FIB-4 (non-invasive biomarkers advanced hepatic fibrosis) | to evaluate the non-invasive biomarkers advanced hepatic fibrosis (FIB-4) | 2 years | 
| e-LIFT (non-invasive biomarkers advanced hepatic fibrosis) | to evaluate the non-invasive biomarkers advanced hepatic fibrosis ( e-LIFT, NAFLD Fibrosis Score) | 2 years | 
| NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis) | to evaluate the non-invasive biomarkers advanced hepatic fibrosis (NAFLD Fibrosis Score) | 2 years | 
| Prevalence of steatosis at diagnosis of Cushing | 4. To assess the performance of CAP (Controlled Attenuation Parameter) in the diagnosis of hepatic steatosis in Cushing's syndrome. | 2 years |