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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00727-38 | Other Identifier | ANSM |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-label study | Other | hepatic MRI, Fibroscan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of steatosis at diagnosis of Cushing | to assess the prevalence of hepatic steatosis at the diagnosis of Cushing's syndrome. | 2 years |
| Prevalence of steatosis at diagnosis of Cushing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire BRIET | Contact | 02 41 35 36 37 | +33 | claire.briet@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claire BRIET | University Hospital of Anger | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Angers | Recruiting | Angers | 49000 | France |
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
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| ID | Term |
|---|---|
| D003480 | Cushing Syndrome |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
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|
to evaluate the prevalence of steatosis
| 2 years |
| Fatty Liver Index (non-invasive biomarkers of hepatic steatosis ) | to evaluate the non-invasive biomarkers of hepatic steatosis (Fatty Liver Index) | 2 years |
| FIB-4 (non-invasive biomarkers advanced hepatic fibrosis) | to evaluate the non-invasive biomarkers advanced hepatic fibrosis (FIB-4) | 2 years |
| e-LIFT (non-invasive biomarkers advanced hepatic fibrosis) | to evaluate the non-invasive biomarkers advanced hepatic fibrosis ( e-LIFT, NAFLD Fibrosis Score) | 2 years |
| NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis) | to evaluate the non-invasive biomarkers advanced hepatic fibrosis (NAFLD Fibrosis Score) | 2 years |
| 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 |
| University Hospital, Bordeaux | Recruiting | Bordeaux | 33604 | France |
|
| University Hospital, Brest | Recruiting | Brest | 29609 | France |
|
| University Hospital, Grenoble | Recruiting | Grenoble | 38043 | France |
|
| University Hospital, Lille | Recruiting | Lille | 59800 | France |
|
| University Hospital, Nantes | Recruiting | Nantes | 44093 | France |
|
| University Hospital, Nancy | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |