The Effect of Growth Hormone Replacement on Liver Fat

Condition(s) targeted: Growth Hormone, Recombinant; Fatty Liver

Phase: N/A

Status: Recruiting

Sponsored by: Imperial College London

Official(s) and/or principal investigator(s):
Fabian A Meienberg, Dr, Study Chair, Affiliation: Imperial College London
Stephen Robinson, Dr, Study Chair, Affiliation: Imperial College London
Jeremy Cox, Dr, Study Chair, Affiliation: Imperial College London
Ian Godsland, Dr, Study Chair, Affiliation: Imperial College London
Jimmy Bell, Dr, Study Chair, Affiliation: Imperial College London
Desmond G Johnston, Prof, Principal Investigator, Affiliation: Imperial College London
Simon Taylor-Robinson, Prof, Study Chair, Affiliation: Imperial College London
Emma Hatfield, Dr, Study Chair, Affiliation: Imperial College London
Michael Yee, Dr, Study Chair, Affiliation: Imperial College London

Overall contact:
Desmond G Johnston, Prof, Phone: 020 7886 1209, Email: d.johnston@imperial.ac.uk

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.

Official title: Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat.

Study design: Cohort, Prospective

Primary outcome: liver fat

Secondary outcome:

inflammatory markers

whole body fat

intramuscular fat

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.

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Desmond G Johnston, Prof, Phone: 020 7886 1209, Email: d.johnston@imperial.ac.uk

Endocrinology & Metabolic Medicine, Imperial College, London W2 1NY, United Kingdom; Recruiting
Desmond G Johnston, Prof, Phone: 020 7886 1209, Email: d.johnston@imperial.ac.uk

Starting date: March 2008
Ending date: September 2009
Last updated: October 16, 2008