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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients with growth hormone (GH) deficiency starting GH replacement. | ||
| 2 | Patients with growth hormone (GH) deficiency not starting GH replacement. |
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| Measure | Description | Time Frame |
|---|---|---|
| Intrahepatocellular Lipid (IHCL) Content | IHCL content determined by proton magnetic resonance spectroscopy (1H MRS). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Adipose Tissue | total adipose tissue assessed by MRI scan | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from the endocrine clinics of Imperial College Healthcare NHS Trust.
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| Name | Affiliation | Role |
|---|---|---|
| Fabian A Meienberg, Dr | Imperial College London | Study Chair |
| Stephen Robinson, Dr | Imperial College London | Study Chair |
| Jeremy Cox, Dr | Imperial College London | Study Chair |
| Ian Godsland, Dr | Imperial College London | Study Chair |
| Jimmy Bell, Dr | Imperial College London | Study Chair |
| Desmond G Johnston, Prof | Imperial College London | Principal Investigator |
| Simon Taylor-Robinson, Prof | Imperial College London | Study Chair |
| Emma Hatfield, Dr | Imperial College London | Study Chair |
| Michael Yee, Dr | Imperial College London | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology & Metabolic Medicine, Imperial College | London | W2 1NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26895949 | Derived | 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. |
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Between April 2008 and April 2009 adult hypopituitary patients with untreated GHD were identified and recruited at the endocrine clinics of Imperial College Healthcare NHS Trust.
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| ID | Title | Description |
|---|---|---|
| FG000 | GH Replacement | Patients with growth hormone (GH) deficiency starting GH replacement. |
| FG001 | Control | Patients with growth hormone (GH) deficiency not starting GH replacement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GH Replacement | Patients with growth hormone (GH) deficiency starting GH replacement. |
| BG001 | Control | Patients with growth hormone (GH) deficiency not starting GH replacement. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intrahepatocellular Lipid (IHCL) Content | IHCL content determined by proton magnetic resonance spectroscopy (1H MRS). | Posted | Mean | Standard Deviation | % change from baseline | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GH Replacement | Patients with growth hormone (GH) deficiency starting GH replacement. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Desmond Johnston | Imperial College Healthcare London | 020 3312 1253 | desmond.johnston@imperial.ac.uk |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
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plasma, serum, leucocytes, 24-hour urine
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Total Adipose Tissue | total adipose tissue assessed by MRI scan | Posted | Mean | Standard Deviation | kg | 6 months |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Control | Patients with growth hormone (GH) deficiency not starting GH replacement. | 0 | 9 | 0 | 9 |
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| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |