NAC- NAFLD And Cushing

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Active Cushing's syndrome

Disqualifiers

Other common causes of chronic liver disease (HBV, HCV, haemochromatosis, alcohol)

Contraindication to MRI

Trial design

Design model

Single group

Treatments tested in this trial

  • hepatic MRI

    Diagnostic test

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: open-label studyOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
2 years

Secondary outcomes

1

Prevalence of steatosis at diagnosis of Cushing

to assess the prevalence of hepatic steatosis at the diagnosis of Cushing's syndrome.

Time frame
2 years
2

Prevalence of steatosis at diagnosis of Cushing

to evaluate the prevalence of steatosis

Time frame
2 years
3

Fatty Liver Index (non-invasive biomarkers of hepatic steatosis )

to evaluate the non-invasive biomarkers of hepatic steatosis (Fatty Liver Index)

Time frame
2 years
4

FIB-4 (non-invasive biomarkers advanced hepatic fibrosis)

to evaluate the non-invasive biomarkers advanced hepatic fibrosis (FIB-4)

Time frame
2 years

Other outcomes

Sponsors and contacts

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