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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
First received
Last updated
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
Health authority
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

Study Design


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
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