Hepatic Steatosis and Pituitary Gland Failure, Evaluation by Nuclear Magnetic Resonance (NMR) Imaging (SHAH)

February 19, 2024 updated by: Centre Hospitalier Universitaire Dijon

Hepatic Steatosis and Pituitary Gland Failure, Evaluation by NMR Imaging

The investigator put forward the hypothesis that liver fat mass in patients with pituitary gland failure is greater than that in a control population. Failure of the anterior pituitary and more particularly impaired production of growth hormone (GH) could be the principal mechanism responsible for increased liver fat mass in these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Chu Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have provided consent
  • Patients over 18 years
  • Patients with pituitary disease (Pituitary adenoma, anterior pituitary failure, craniopharyngioma, empty sella syndrome, hypophysitis, infiltration of the stalk) requiring Magnetic Resonance Imaging (MRI) of the pituitary.

Exclusion Criteria:

  • Persons without national health insurance
  • Pacemaker (Contra-Indication for MRI)
  • Alcohol consumption greater than 4 glasses a day
  • Any treatment able to increase liver fat content (glitazones, systemic corticoids, immunosuppressants) are forbidden
  • Presence of metallic implants (Contra-Indication for MRI)
  • Claustrophobia
  • Adult under guardianship
  • Pregnant or breast-feeding women
  • Patients with a liver disease other than non-alcoholic steatosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pituitary gland failure
Biological: Blood samples
Other: NMR
Other: fibroscan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of liver fat mass by Magnetic Resonance Imaging (MRI)
Time Frame: Measured at Day 0
Measured at Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2015

Primary Completion (Actual)

October 10, 2015

Study Completion (Actual)

October 10, 2015

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimated)

June 27, 2016

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PETIT NOVARTIS 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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