Skip to content

NAC- NAFLD And Cushing

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05881005
Acronym
NAC
Enrollment
100
Registered
2023-05-30
Start date
2023-09-28
Completion date
2029-09-28
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cushing Syndrome, Fatty Liver Disease

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.

Interventions

DIAGNOSTIC_TESThepatic 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.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of resolution of hepatic steatosis2 yearsTo evaluate the frequency of complete resolution of hepatic steatosis in patients with cushing syndrome after remission of hypercortisolism

Secondary

MeasureTime frameDescription
Prevalence of steatosis at diagnosis of Cushing2 yearsto assess the prevalence of hepatic steatosis at the diagnosis of Cushing's syndrome.
Fatty Liver Index (non-invasive biomarkers of hepatic steatosis )2 yearsto evaluate the non-invasive biomarkers of hepatic steatosis (Fatty Liver Index)
FIB-4 (non-invasive biomarkers advanced hepatic fibrosis)2 yearsto evaluate the non-invasive biomarkers advanced hepatic fibrosis (FIB-4)
e-LIFT (non-invasive biomarkers advanced hepatic fibrosis)2 yearsto evaluate the non-invasive biomarkers advanced hepatic fibrosis ( e-LIFT, NAFLD Fibrosis Score)
NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis)2 yearsto evaluate the non-invasive biomarkers advanced hepatic fibrosis (NAFLD Fibrosis Score)

Countries

France

Contacts

CONTACTClaire BRIET
claire.briet@chu-angers.fr02 41 35 36 37
PRINCIPAL_INVESTIGATORClaire BRIET

University Hospital of Anger

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026