search
Back to results

NAC- NAFLD And Cushing (NAC)

Primary Purpose

Cushing Syndrome, Fatty Liver Disease

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hepatic MRI
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cushing Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, Angers
  • University Hospital, Bordeaux
  • University Hospital, Brest
  • University Hospital, Grenoble
  • University Hospital, Nantes
  • University Hospital, Rennes

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

open-label study

Arm Description

hepatic MRI, Fibroscan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevalence of steatosis at diagnosis of Cushing
to assess the prevalence of hepatic steatosis at the diagnosis of Cushing's syndrome.
Prevalence of steatosis at diagnosis of Cushing
to evaluate the prevalence of steatosis
Fatty Liver Index (non-invasive biomarkers of hepatic steatosis )
to evaluate the non-invasive biomarkers of hepatic steatosis (Fatty Liver Index)
FIB-4 (non-invasive biomarkers advanced hepatic fibrosis)
to evaluate the non-invasive biomarkers advanced hepatic fibrosis (FIB-4)
e-LIFT (non-invasive biomarkers advanced hepatic fibrosis)
to evaluate the non-invasive biomarkers advanced hepatic fibrosis ( e-LIFT, NAFLD Fibrosis Score)
NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis)
to evaluate the non-invasive biomarkers advanced hepatic fibrosis (NAFLD Fibrosis Score)
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.

Full Information

First Posted
May 5, 2023
Last Updated
July 28, 2023
Sponsor
University Hospital, Angers
search

1. Study Identification

Unique Protocol Identification Number
NCT05881005
Brief Title
NAC- NAFLD And Cushing
Acronym
NAC
Official Title
Prévalence de la stéato-fibrose hépatique Dans le Syndrome de Cushing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
May 2028 (Anticipated)
Study Completion Date
May 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing Syndrome, Fatty Liver Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
open-label study
Arm Type
Other
Arm Description
hepatic MRI, Fibroscan
Intervention Type
Diagnostic Test
Intervention Name(s)
hepatic MRI
Other Intervention Name(s)
Fibroscan
Intervention Description
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 Measure Information:
Title
Frequency of resolution of hepatic steatosis
Description
To evaluate the frequency of complete resolution of hepatic steatosis in patients with cushing syndrome after remission of hypercortisolism
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Prevalence of steatosis at diagnosis of Cushing
Description
to assess the prevalence of hepatic steatosis at the diagnosis of Cushing's syndrome.
Time Frame
2 years
Title
Prevalence of steatosis at diagnosis of Cushing
Description
to evaluate the prevalence of steatosis
Time Frame
2 years
Title
Fatty Liver Index (non-invasive biomarkers of hepatic steatosis )
Description
to evaluate the non-invasive biomarkers of hepatic steatosis (Fatty Liver Index)
Time Frame
2 years
Title
FIB-4 (non-invasive biomarkers advanced hepatic fibrosis)
Description
to evaluate the non-invasive biomarkers advanced hepatic fibrosis (FIB-4)
Time Frame
2 years
Title
e-LIFT (non-invasive biomarkers advanced hepatic fibrosis)
Description
to evaluate the non-invasive biomarkers advanced hepatic fibrosis ( e-LIFT, NAFLD Fibrosis Score)
Time Frame
2 years
Title
NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis)
Description
to evaluate the non-invasive biomarkers advanced hepatic fibrosis (NAFLD Fibrosis Score)
Time Frame
2 years
Title
Prevalence of steatosis at diagnosis of Cushing
Description
4. To assess the performance of CAP (Controlled Attenuation Parameter) in the diagnosis of hepatic steatosis in Cushing's syndrome.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire BRIET
Organizational Affiliation
University Hospital of Anger
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
University Hospital, Bordeaux
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Facility Name
University Hospital, Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
University Hospital, Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
University Hospital, Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
University Hospital, Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

NAC- NAFLD And Cushing

We'll reach out to this number within 24 hrs