Hepatic Steatosis and Pituitary Gland Failure, Evaluation... | NCT02814240

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

NCT02814240

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Feb 21, 2024Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Hepatic Steatosis
Pituitary Gland Failure

Interventions

NMR
Blood samples
fibroscan

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 16, 2015Actual

Primary Completion Date

Oct 10, 2015Actual

Completion Date

Oct 10, 2015Actual

First Submitted Date

Jun 23, 2016

First Submission Date that Met QC Criteria

Jun 24, 2016

First Posted Date

Jun 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2024

Last Update Posted Date

Feb 21, 2024Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Label	Type	Description	Intervention Names
Pituitary gland failure	Experimental		Other: NMR Biological: Blood samples Other: fibroscan

Name	Type	Description	Arm Group Labels	Other Names
NMR	Other		Pituitary gland failure
Blood samples

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Dijon Bourgogne		Dijon		21079	France

Condition Browse Module

MeSH Terms

ID	Term
D005234	Fatty Liver

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided