Clinical trial NCT00774579: The Effect of Growth Hormone Replacement on Liver Fat
Official title: Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone, Recombinant
Fatty Liver
Keywords: growth hormone
growth hormone deficiency
liver fat
liver steatosis
growth hormone replacement
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2008-10-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the endocrine clinics of Imperial College Healthcare NHS Trust.

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.

Eligibility 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

Primary outcomes:
measure: Intrahepatocellular Lipid (IHCL) Content
timeFrame: 6 months
Secondary outcomes:
measure: Total Adipose Tissue
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Endocrinology & Metabolic Medicine, Imperial College
Study officials:
affiliation: Imperial College London
name: Fabian A Meienberg, Dr
role: STUDY_CHAIR
affiliation: Imperial College London
name: Stephen Robinson, Dr
role: STUDY_CHAIR
affiliation: Imperial College London
name: Jeremy Cox, Dr
role: STUDY_CHAIR
affiliation: Imperial College London
name: Ian Godsland, Dr
role: STUDY_CHAIR
affiliation: Imperial College London
name: Jimmy Bell, Dr
role: STUDY_CHAIR
affiliation: Imperial College London
name: Desmond G Johnston, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Simon Taylor-Robinson, Prof
role: STUDY_CHAIR
affiliation: Imperial College London
name: Emma Hatfield, Dr
role: STUDY_CHAIR
affiliation: Imperial College London
name: Michael Yee, Dr
role: STUDY_CHAIR
References:
citation: 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.