Growth Hormone, RecombinantNCT00774579
The Effect of Growth Hormone Replacement on Liver Fat
An observational study of Growth Hormone, Recombinant and Fatty Liver, run by Imperial College London at 1 site in United Kingdom.
Trial summary
We will examine a cohort of growth hormone deficient adults starting growth hormone (GH) replacement. The purpose of this study is to determine whether GH replacement reduces the fat content of the liver. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Growth Hormone, Recombinant, Fatty Liver
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2008to Oct 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the endocrine clinics of Imperial College Healthcare NHS Trust.
Who may be able to join
- 20-70 years of age
- Growth hormone deficiency, with (cohort 1) or without (cohort 2) planned growth hormone (GH) replacement
- clinically stable
Who cannot join
- known hepatic disease
- Acromegaly
- Diabetes mellitus
- growth hormone replacement within the last 12 months
- cushing's disease, if not cured for at least 12 months
- any contraindication to MR studies as set out in the MR safety questionnaire
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Endocrinology & Metabolic Medicine, Imperial College
London, W2 1NY
About this study
Official title: Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat.
We will examine a cohort of growth hormone deficient adults starting growth hormone (GH) replacement. The purpose of this study is to determine whether GH replacement reduces the fat content of the liver.
To compare the results we will include growth hormone deficient patients who do not start GH replacement as controls.
Read the detailed description
Adults with untreated growth hormone deficiency (GHD), a condition mostly due to pituitary disease, often show metabolic features similar to those described in the 'metabolic syndrome'. Growth hormone (GH) replacement has been shown to reverse many of these unfavorable changes, with a particular evident reduction of visceral fat. In recent years, a strong correlation between fat accumulation in the liver and features of the metabolic syndrome (particularly visceral fat) has been identified, and 'fatty liver' is now being referred as the hepatic feature of the 'metabolic syndrome'. The effect of GH replacement on liver fat, however, has never been systematically studied.
We will assess 15 patients with GHD before and 6 months after starting GH replacement. We will also assess 15 control patients with GHD but who don't go on GH replacement for various reasons.
Liver fat will be assessed using MR spectroscopy. Changes in liver fat will be correlated to changes in insulin sensitivity and changes in various inflammatory markers.
- Conditions
- Growth Hormone, Recombinant, Fatty Liver
- Keywords
- growth hormone, growth hormone deficiency, liver fat, liver steatosis, growth hormone replacement
- Medical subject headings
- Fatty Liver, Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with growth hormone (GH) deficiency starting GH replacement. | |
| 2 | Patients with growth hormone (GH) deficiency not starting GH replacement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrahepatocellular Lipid (IHCL) Content
IHCL content determined by proton magnetic resonance spectroscopy (1H MRS).
Measured: 6 months
Secondary outcomes (1)
Total Adipose Tissue
total adipose tissue assessed by MRI scan
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone, RecombinantStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Fabian A Meienberg, Dr, Study chair, Imperial College LondonStephen Robinson, Dr, Study chair, Imperial College LondonJeremy Cox, Dr, Study chair, Imperial College LondonIan Godsland, Dr, Study chair, Imperial College LondonJimmy Bell, Dr, Study chair, Imperial College LondonDesmond G Johnston, Prof, Principal investigator, Imperial College LondonSimon Taylor-Robinson, Prof, Study chair, Imperial College LondonEmma Hatfield, Dr, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774579
- Sponsor's protocol ID
- GHD1
- Status last verified
- Dec 2009
- First submitted
- 16 Oct 2008
- Last updated
- 12 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Meienberg F, Yee M, Johnston D, Cox J, Robinson S, Bell JD, Thomas EL, Taylor-Robinson SD, Godsland I. Liver fat in adults with GH deficiency: comparison to matched controls and the effect of GH replacement. Clin Endocrinol (Oxf). 2016 Jul;85(1):76-84. doi: 10.1111/cen.13042. Epub 2016 Mar 22.
PubMed 26895949
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat.
- ClinicalTrials.gov ID
- NCT00774579
- Acronym / sponsor ID
- GHD1
- Conditions
- Growth Hormone, Recombinant, Fatty Liver
- Keywords
- growth hormone, growth hormone deficiency, liver fat, liver steatosis, growth hormone replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Posted 12 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will examine a cohort of growth hormone deficient adults starting growth hormone (GH) replacement. The purpose of this study is to determine whether GH replacement reduces the fat content of the liver.
To compare the results we will include growth hormone deficient patients who do not start GH replacement as controls.
Detailed description
Adults with untreated growth hormone deficiency (GHD), a condition mostly due to pituitary disease, often show metabolic features similar to those described in the 'metabolic syndrome'. Growth hormone (GH) replacement has been shown to reverse many of these unfavorable changes, with a particular evident reduction of visceral fat. In recent years, a strong correlation between fat accumulation in the liver and features of the metabolic syndrome (particularly visceral fat) has been identified, and 'fatty liver' is now being referred as the hepatic feature of the 'metabolic syndrome'. The effect of GH replacement on liver fat, however, has never been systematically studied.
We will assess 15 patients with GHD before and 6 months after starting GH replacement. We will also assess 15 control patients with GHD but who don't go on GH replacement for various reasons.
Liver fat will be assessed using MR spectroscopy. Changes in liver fat will be correlated to changes in insulin sensitivity and changes in various inflammatory markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with growth hormone (GH) deficiency starting GH replacement. |
| 2 | – | –Patients with growth hormone (GH) deficiency not starting GH replacement. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the endocrine clinics of Imperial College Healthcare NHS Trust.
Key inclusion criteria (3 listed)
- 20-70 years of age
- Growth hormone deficiency, with (cohort 1) or without (cohort 2) planned growth hormone (GH) replacement
- clinically stable
Key exclusion criteria (6 listed)
- known hepatic disease
- Acromegaly
- Diabetes mellitus
- growth hormone replacement within the last 12 months
- cushing's disease, if not cured for at least 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intrahepatocellular Lipid (IHCL) Content
Time frame: 6 months
IHCL content determined by proton magnetic resonance spectroscopy (1H MRS).
1 secondary outcome
Total Adipose Tissue
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26895949Meienberg F, Yee M, Johnston D, Cox J, Robinson S, Bell JD, Thomas EL, Taylor-Robinson SD, Godsland I. Liver fat in adults with GH deficiency: comparison to matched controls and the effect of GH replacement. Clin Endocrinol (Oxf). 2016 Jul;85(1):76-84. doi: 10.1111/cen.13042. Epub 2016 Mar 22.
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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.
Fabian A Meienberg, Dr study chair
Imperial College London
Stephen Robinson, Dr study chair
Imperial College London
Jeremy Cox, Dr study chair
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone, Recombinant and Fatty Liver, run by Imperial College London at 1 site in United Kingdom.
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 6 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 12 Jul 2019. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 12 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intrahepatocellular Lipid (IHCL) Content (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00774579, which also lists 1 linked publication.
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 12 Jul 2019.