NAC- NAFLD And Cushing

Not Applicable

Recruiting

• Conditions: Fatty Liver Disease; Cushing Syndrome
• Interventions: Diagnostic Test: hepatic MRI

• Registration Number: NCT05881005
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-25
• Study First Posted: 2023-05-30
• Study Start: 2023-09-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-10-28
• Study Completion: 2027-09-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open-label study	hepatic MRI	hepatic MRI, Fibroscan

Primary Outcome Measures

Name	Time	Method
Frequency of resolution of hepatic steatosis	2 years	To evaluate the frequency of complete resolution of hepatic steatosis in patients with cushing syndrome after remission of hypercortisolism

Secondary Outcome Measures

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

Trial Locations

Locations (6)

University Hospital, Angers; 🇫🇷 Angers, France

University Hospital, Bordeaux; 🇫🇷 Bordeaux, France

University Hospital, Brest; 🇫🇷 Brest, France

University Hospital, Grenoble; 🇫🇷 Grenoble, France

University Hospital, Nantes; 🇫🇷 Nantes, France

University Hospital, Rennes; 🇫🇷 Rennes, France