Hepatic SteatosisSHAHNCT02814240
Hepatic Steatosis and Pituitary Gland Failure, Evaluation by Nuclear Magnetic Resonance (NMR) Imaging
A study testing NMR, Blood samples and fibroscan in people with Hepatic Steatosis and Pituitary Gland Failure, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Steatosis, Pituitary Gland Failure
- What is being tested?
- NMR, Blood samples and fibroscan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2015to 10 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Adult under guardianship
- Pregnant or breast-feeding women
- Patients with a liver disease other than non-alcoholic steatosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatic Steatosis, Pituitary Gland Failure
- Being tested
- NMR, Blood samples, fibroscan
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMROther
Blood samplesBiological
fibroscanOther
| Study group | Role | What they receive |
|---|---|---|
| Pituitary gland failure | Experimental | Not described Receives: Other: NMR; Biological: Blood samples; Other: fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of liver fat mass by Magnetic Resonance Imaging (MRI)
Measured: Measured at Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start16 Mar 2015
- Primary completion10 Oct 2015
- Study completion10 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic SteatosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814240
- Sponsor's protocol ID
- PETIT NOVARTIS 2014
- Acronym
- SHAH
- Status last verified
- Feb 2024
- First submitted
- 23 Jun 2016
- Last updated
- 21 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Steatosis and Pituitary Gland Failure, Evaluation by NMR Imaging
- ClinicalTrials.gov ID
- NCT02814240
- Acronym / sponsor ID
- SHAH / PETIT NOVARTIS 2014
- Conditions
- Hepatic Steatosis, Pituitary Gland Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- 10 Oct 2015 (actual)
- Study completion
- 10 Oct 2015 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pituitary gland failure | Experimental | Other: NMR, Biological: Blood samples, Other: fibroscan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMR | Other | Pituitary gland failure |
| Blood samples | Biological | Pituitary gland failure |
| fibroscan | Other | Pituitary gland failure |
Primary outcome
Measurement of liver fat mass by Magnetic Resonance Imaging (MRI)
Time frame: Measured at Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMR, Blood samples and fibroscan in people with Hepatic Steatosis and Pituitary Gland Failure, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of liver fat mass by Magnetic Resonance Imaging (MRI) (time frame: Measured at Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.