NCT02814240

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

June 23, 2016

Last Update Submit

February 19, 2024

Conditions

Hepatic SteatosisPituitary Gland Failure

Outcome Measures

Primary Outcomes (1)

  • Measurement of liver fat mass by Magnetic Resonance Imaging (MRI)

    Measured at Day 0

Study Arms (1)

Pituitary gland failure

EXPERIMENTAL
Other: NMRBiological: Blood samplesOther: fibroscan

Interventions

NMROTHER
Pituitary gland failure
Blood samplesBIOLOGICAL
Pituitary gland failure
fibroscanOTHER
Pituitary gland failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Fatty Liver

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 27, 2016

Study Start

March 16, 2015

Primary Completion

October 10, 2015

Study Completion

October 10, 2015

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations

FR(1)