Fatty Liver, Growth Hormone, Recombinant
Conditions
Keywords
growth hormone, growth hormone deficiency, liver fat, liver steatosis, growth hormone replacement
Brief 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. 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.
Interventions
None listed
Sponsors
Novo Nordisk A/S
Imperial College London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 20-70 years of age * Growth hormone deficiency, with (cohort 1) or without (cohort 2) planned growth hormone (GH) replacement * clinically stable
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrahepatocellular Lipid (IHCL) Content | 6 months | IHCL content determined by proton magnetic resonance spectroscopy (1H MRS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Adipose Tissue | 6 months | total adipose tissue assessed by MRI scan |
Countries
United Kingdom
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| GH Replacement Patients with growth hormone (GH) deficiency starting GH replacement. | 9 |
| Control Patients with growth hormone (GH) deficiency not starting GH replacement. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | GH Replacement | Control | Total |
|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 8 | 52 years STANDARD_DEVIATION 9 | 52 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Intrahepatocellular Lipid (IHCL) Content
IHCL content determined by proton magnetic resonance spectroscopy (1H MRS).
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GH Replacement | Intrahepatocellular Lipid (IHCL) Content | -0.63 % change from baseline | Standard Deviation 4.53 |
| Control | Intrahepatocellular Lipid (IHCL) Content | 0.11 % change from baseline | Standard Deviation 1.46 |
p-value: 0.6t-test, 2 sided
Secondary
Total Adipose Tissue
total adipose tissue assessed by MRI scan
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GH Replacement | Total Adipose Tissue | -1.8 kg | Standard Deviation 3.2 |
| Control | Total Adipose Tissue | 0.24 kg | Standard Deviation 2.28 |
p-value: 0.1t-test, 2 sided