The Effect of Growth Hormone Replacement 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.
Growth Hormone, Recombinant
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat.|
- liver fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- inflammatory markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- whole body fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- intramuscular fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
plasma, serum, leucocytes, 24-hour urine
|Study Start Date:||March 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Patients with growth hormone (GH) deficiency starting GH replacement.
Patients with growth hormone (GH) deficiency not starting GH replacement.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774579
|Endocrinology & Metabolic Medicine, Imperial College|
|London, United Kingdom, W2 1NY|
|Study Chair:||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|
|Principal Investigator:||Desmond G Johnston, Prof||Imperial College London|
|Study Chair:||Simon Taylor-Robinson, Prof||Imperial College London|
|Study Chair:||Emma Hatfield, Dr||Imperial College London|
|Study Chair:||Michael Yee, Dr||Imperial College London|