Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05881005

Prevalence of Hepatic Steatosis and Fibrosis in Cushing's Syndrome

Led by University Hospital, Angers · Updated on 2024-12-16

100

Participants Needed

6

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Cushing's Syndrome is a rare condition caused by prolonged high levels of cortisol in the body. Many patients experience metabolic issues such as abdominal obesity, insulin resistance, abnormal blood fats, and high blood pressure. Excess cortisol may also lead to fat buildup in the liver, but little data exists in humans about this effect. Non-Alcoholic Fatty Liver Disease (NAFLD) involves fat accumulation in the liver without other causes, ranging from mild steatosis to severe inflammation and scarring, and its severity affects prognosis. This study evaluates the presence and resolution of liver fat accumulation in patients with active Cushing's Syndrome. Participants will undergo hepatic MRI scans and Fibroscan assessments to measure liver fat and fibrosis at diagnosis and one year after remission. The study involves an open-label approach with diagnostic tests to track changes in liver condition over two years. Participants will be monitored through imaging tests including hepatic MRI and Fibroscan to assess liver fat and fibrosis levels. Researchers will measure the frequency of complete resolution of hepatic steatosis over two years, along with various non-invasive biomarkers to evaluate liver health. Safety and follow-up will continue throughout the study period, which lasts up to two years from diagnosis.

CONDITIONS

Brief Title

NAC- NAFLD and Cushing

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Active Cushing's syndrome
Not Eligible

You will not qualify if you...

  • Other common causes of chronic liver disease such as hepatitis B, hepatitis C, haemochromatosis, or alcohol-related liver disease
  • Contraindication to MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 2 years

Participants undergo hepatic MRI to assess hepatic steatosis at diagnosis and one year after remission of Cushing's syndrome.

2 visits (in-person)

Trial Site Locations

Total: 6 locations

1

University Hospital, Angers

Angers, France, 49000

Actively Recruiting

2

University Hospital, Bordeaux

Bordeaux, France, 33604

Actively Recruiting

3

University Hospital, Brest

Brest, France, 29609

Actively Recruiting

4

University Hospital, Grenoble

Grenoble, France, 38043

Actively Recruiting

5

University Hospital, Nantes

Nantes, France, 44093

Actively Recruiting

6

University Hospital, Rennes

Rennes, France, 35000

Not Yet Recruiting

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Research Team

C

Claire BRIET

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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