NAC- NAFLD And Cushing

Cushing Syndrome Clinical Trial

— NAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881005
• Other study ID #: 49RC22-0389
• Secondary ID: 2023-A00727-38
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: September 28, 2027

Study information

• Verified date: May 2024
• Source: University Hospital, Angers
• Contact: Claire BRIET
• Phone: 02 41 35 36 37
• Email: claire.briet[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 28, 2027
• Est. primary completion date: October 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cushing Syndrome
• Fatty Liver
• Fatty Liver Disease
• Liver Diseases
• Syndrome

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of steatosis at diagnosis of Cushing	to assess the prevalence of hepatic steatosis at the diagnosis of Cushing's syndrome.	2 years
Secondary	Prevalence of steatosis at diagnosis of Cushing	to evaluate the prevalence of steatosis	2 years
Secondary	Fatty Liver Index (non-invasive biomarkers of hepatic steatosis )	to evaluate the non-invasive biomarkers of hepatic steatosis (Fatty Liver Index)	2 years
Secondary	FIB-4 (non-invasive biomarkers advanced hepatic fibrosis)	to evaluate the non-invasive biomarkers advanced hepatic fibrosis (FIB-4)	2 years
Secondary	e-LIFT (non-invasive biomarkers advanced hepatic fibrosis)	to evaluate the non-invasive biomarkers advanced hepatic fibrosis ( e-LIFT, NAFLD Fibrosis Score)	2 years
Secondary	NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis)	to evaluate the non-invasive biomarkers advanced hepatic fibrosis (NAFLD Fibrosis Score)	2 years
Secondary	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