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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02814240
• Collaborator: (none)
• Enrollment: 166
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Steatosis; Pituitary Gland Failure	Other: NMR; Biological: Blood samples; Other: fibroscan	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 166 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Hepatic Steatosis and Pituitary Gland Failure, Evaluation by NMR Imaging
• Study Start Date: Mar 1, 2015
• Anticipated Primary Completion Date: Mar 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Measurement of liver fat mass by Magnetic Resonance Imaging (MRI) [Measured at Day 0]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dijon Bourgogne	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT02814240
• Other Study ID Numbers: PETIT NOVARTIS 2014
• First Posted: Jun 27, 2016
• Last Update Posted: Jun 27, 2016
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Fatty Liver; Pituitary Diseases

Study Results

No Results Posted as of Jun 27, 2016