Cushing SyndromeNACNCT05881005
NAC- NAFLD And Cushing
A study testing hepatic MRI in people with Cushing Syndrome and Fatty Liver Disease, run by University Hospital, Angers at 7 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Syndrome, Fatty Liver Disease
- What is being tested?
- hepatic MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesFrance
- Study dates
- 28 Sep 2023to 28 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Active Cushing's syndrome
Who cannot join
- Other common causes of chronic liver disease (HBV, HCV, haemochromatosis, alcohol)
- Contraindication to MRI
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
University Hospital, Angers
Angers, 49000
Claire BRIET, MD, 0241353637 ext. +33, claire.briet@chu-angers.fr
- Recruiting
University Hospital, Bordeaux
Bordeaux, 33604
Amandine FERRIERE, PHD, 05.57.65.60.78, amandine.ferriere@chu-bordeaux.fr
- Recruiting
University Hospital, Brest
Brest, 29609
PHILIPPE TUILLIER, MD, 02 30 33 76 23 ext. +33, philippe.thuillier@chu-brest.fr
- Recruiting
University Hospital, Grenoble
Grenoble, 38043
JUSTINE CRISTANTE, PHD, 04 76 76 55 09 ext. +33, jcristante@chu-grenoble.fr
- Recruiting
University Hospital, Lille
Lille, 59800
STEPHANIE ESPIARD, MD, 03 20 44 45 15, stephanie.espiard@chu-lille.fr
- Recruiting
University Hospital, Nantes
Nantes, 44093
Sarra SMATI GRANGEON, PHD, 02 53 48 27 19 ext. +33, sarra.grangeon@chu-nantes.fr
- Recruiting
University Hospital, Nancy
Vandœuvre-lès-Nancy, 54500
NICOLAS SCHEYER, PHD, 03 83 15 50 36., n.scheyer@chru-nancy.fr
About this study
Official title: Prévalence de la stéato-fibrose hépatique Dans le Syndrome de 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.
- Conditions
- Cushing Syndrome, Fatty Liver Disease
- Being tested
- hepatic MRI
- Medical subject headings
- Cushing Syndrome, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic MRIDiagnostic test
Also called Fibroscan
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.
| Study group | Role | What they receive |
|---|---|---|
| open-label study | Other | hepatic MRI, Fibroscan Receives: Diagnostic Test: hepatic MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (7)
Prevalence of steatosis at diagnosis of Cushing
to assess the prevalence of hepatic steatosis at the diagnosis of Cushing's syndrome.
Measured: 2 years
Prevalence of steatosis at diagnosis of Cushing
to evaluate the prevalence of steatosis
Measured: 2 years
Fatty Liver Index (non-invasive biomarkers of hepatic steatosis )
to evaluate the non-invasive biomarkers of hepatic steatosis (Fatty Liver Index)
Measured: 2 years
FIB-4 (non-invasive biomarkers advanced hepatic fibrosis)
to evaluate the non-invasive biomarkers advanced hepatic fibrosis (FIB-4)
Measured: 2 years
e-LIFT (non-invasive biomarkers advanced hepatic fibrosis)
to evaluate the non-invasive biomarkers advanced hepatic fibrosis ( e-LIFT, NAFLD Fibrosis Score)
Measured: 2 years
NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis)
to evaluate the non-invasive biomarkers advanced hepatic fibrosis (NAFLD Fibrosis Score)
Measured: 2 years
Prevalence of steatosis at diagnosis of Cushing
- To assess the performance of CAP (Controlled Attenuation Parameter) in the diagnosis of hepatic steatosis in Cushing's syndrome.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start28 Sep 2023
- Primary completion28 Sep 2027 (estimated)
- Study completion28 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Claire BRIET, Principal investigator, University Hospital of Anger
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881005
- Sponsor's protocol ID
- 49RC22-0389
- Other IDs
- 2023-A00727-38
- Acronym
- NAC
- Status last verified
- Jul 2026
- First submitted
- 5 May 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prévalence de la stéato-fibrose hépatique Dans le Syndrome de Cushing
- ClinicalTrials.gov ID
- NCT05881005
- Acronym / sponsor ID
- NAC / 49RC22-0389
- Conditions
- Cushing Syndrome, Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 28 Sep 2027 (estimated)
- Study completion
- 28 Sep 2029 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open-label study | Other | Diagnostic Test: hepatic MRIhepatic MRI, Fibroscan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Active Cushing's syndrome
Key exclusion criteria (2 listed)
- Other common causes of chronic liver disease (HBV, HCV, haemochromatosis, alcohol)
- Contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepatic MRIAlso: FibroscanQuantification 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. | Diagnostic test | open-label study |
Primary outcome
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
7 secondary outcomes
Prevalence of steatosis at diagnosis of Cushing
Time frame: 2 years
Prevalence of steatosis at diagnosis of Cushing
Time frame: 2 years
Fatty Liver Index (non-invasive biomarkers of hepatic steatosis )
Time frame: 2 years
FIB-4 (non-invasive biomarkers advanced hepatic fibrosis)
Time frame: 2 years
e-LIFT (non-invasive biomarkers advanced hepatic fibrosis)
Time frame: 2 years
NAFLD Fibrosis Score (non-invasive biomarkers advanced hepatic fibrosis)
Time frame: 2 years
Prevalence of steatosis at diagnosis of Cushing
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Cushing Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claire BRIET principal investigator
University Hospital of Anger
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hepatic MRI in people with Cushing Syndrome and Fatty Liver Disease, run by University Hospital, Angers at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire BRIET (02 41 35 36 37 ext. +33, claire.briet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of resolution of hepatic steatosis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.