Clinical trial NCT05881005: NAC- NAFLD and Cushing
Official title: Prévalence De La Stéato-fibrose Hépatique Dans Le Syndrome De Cushing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cushing Syndrome
Fatty Liver Disease
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of resolution of hepatic steatosis
timeFrame: 2 years
Secondary outcomes:
measure: Prevalence of steatosis at diagnosis of Cushing
timeFrame: 2 years
measure: Prevalence of steatosis at diagnosis of Cushing
timeFrame: 2 years
measure: Fatty Liver Index (non-invasive biomarkers of hepatic steatosis )
timeFrame: 2 years
measure: FIB-4 (non-invasive biomarkers advanced hepatic fibrosis)
timeFrame: 2 years
measure: e-LIFT (non-invasive biomarkers advanced hepatic fibrosis)
timeFrame: 2 years
measure: NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis)
timeFrame: 2 years
measure: Prevalence of steatosis at diagnosis of Cushing
timeFrame: 2 years
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital, Angers
city: Bordeaux
country: France
facility: University Hospital, Bordeaux
city: Brest
country: France
facility: University Hospital, Brest
city: Grenoble
country: France
facility: University Hospital, Grenoble
city: Nantes
country: France
facility: University Hospital, Nantes
city: Rennes
country: France
facility: University Hospital, Rennes
Study officials:
affiliation: University Hospital of Anger
name: Claire BRIET
role: PRINCIPAL_INVESTIGATOR
References: