NAC- NAFLD and Cushing

NCT05881005 | Recruiting

• 2 other identifiers: 49RC22-03892023-A00727-38
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

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.

Conditions

Cushing Syndrome; Fatty Liver Disease

Outcome Measures

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

  2 years

Secondary Outcomes (7)

• Prevalence of steatosis at diagnosis of Cushing

  2 years

• Prevalence of steatosis at diagnosis of Cushing

  2 years

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

  2 years

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

  2 years

• e-LIFT (non-invasive biomarkers advanced hepatic fibrosis)

  2 years

Study Arms (1)

open-label study

OTHER

hepatic MRI, Fibroscan

Diagnostic Test: hepatic MRI

Interventions

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.

Also known as: Fibroscan

open-label study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Active Cushing's syndrome

You may not qualify if:

• Other common causes of chronic liver disease (HBV, HCV, haemochromatosis, alcohol)
• Contraindication to MRI

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (6)

University Hospital, Angers

Angers, 49000, France

RECRUITING

University Hospital, Bordeaux

Bordeaux, 33604, France

RECRUITING

University Hospital, Brest

Brest, 29609, France

RECRUITING

University Hospital, Grenoble

Grenoble, 38043, France

RECRUITING

University Hospital, Nantes

Nantes, 44093, France

RECRUITING

University Hospital, Rennes

Rennes, 35000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Cushing Syndrome; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Claire BRIET

  University Hospital of Anger

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire BRIET

CONTACT

02 41 35 36 37; claire.briet@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 30, 2023
• Study Start: September 28, 2023
• Primary Completion: October 28, 2025
• Study Completion (Estimated): September 28, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)