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Recruiting NCT05881005

NAC- NAFLD And Cushing

No phase Interventional Cushing Syndrome Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hepatic MRI.
Who it may be relevant to
Registry conditions: Cushing Syndrome, Fatty Liver Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 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.

Primary outcome measures

  • Frequency of resolution of hepatic steatosis [Time frame: 2 years]
Secondary outcome measures (7)
  • Prevalence of steatosis at diagnosis of Cushing [Time frame: 2 years]
  • Prevalence of steatosis at diagnosis of Cushing [Time frame: 2 years]
  • Fatty Liver Index (non-invasive biomarkers of hepatic steatosis ) [Time frame: 2 years]
  • FIB-4 (non-invasive biomarkers advanced hepatic fibrosis) [Time frame: 2 years]
  • e-LIFT (non-invasive biomarkers advanced hepatic fibrosis) [Time frame: 2 years]
  • NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis) [Time frame: 2 years]
  • Prevalence of steatosis at diagnosis of Cushing [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 7 centers
  • University Hospital, Angers — Angers
  • University Hospital, Bordeaux — Bordeaux
  • University Hospital, Brest — Brest
  • University Hospital, Grenoble — Grenoble
  • University Hospital, Lille — Lille
  • University Hospital, Nantes — Nantes
  • University Hospital, Nancy — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT05881005 · 49RC22-0389 · 2023-A00727-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗