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NCT Number: NCT05881005

NAC- NAFLD And Cushing

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Fibroscan

Primary outcomes

  1. Frequency of resolution of hepatic steatosis

    Time frame: 2 years

    To evaluate the frequency of complete resolution of hepatic steatosis in patients with cushing syndrome after remission of hypercortisolism

Secondary outcomes

  1. Prevalence of steatosis at diagnosis of Cushing

    Time frame: 2 years

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

  2. Prevalence of steatosis at diagnosis of Cushing

    Time frame: 2 years

    to evaluate the prevalence of steatosis

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

    Time frame: 2 years

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

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

    Time frame: 2 years

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

  5. e-LIFT (non-invasive biomarkers advanced hepatic fibrosis)

    Time frame: 2 years

    to evaluate the non-invasive biomarkers advanced hepatic fibrosis ( e-LIFT, NAFLD Fibrosis Score)

  6. NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis)

    Time frame: 2 years

    to evaluate the non-invasive biomarkers advanced hepatic fibrosis (NAFLD Fibrosis Score)

  7. Prevalence of steatosis at diagnosis of Cushing

    Time frame: 2 years

    • To assess the performance of CAP (Controlled Attenuation Parameter) in the diagnosis of hepatic steatosis in Cushing's syndrome.

Study contacts

Contact information is provided by the study sponsor or research team.

Claire BRIET

CONTACT

[email protected]

02 41 35 36 37 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: NAC

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
May 30, 2023
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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