The Effect of Growth Hormone Replacement on Liver Fat

Completed

• Conditions: Growth Hormone, Recombinant; Fatty Liver

• Registration Number: NCT00774579
• Lead Sponsor: Imperial College London

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Primary Completion: 2009-03
• Study Completion: 2009-10
• Status Verified: 2009-12
• Results First Submitted: 2019-04-29
• Results First Submitted QC: 2019-04-29
• Last Update Submitted: 2019-04-29
• Results First Posted: 2019-07-12
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intrahepatocellular Lipid (IHCL) Content	6 months	IHCL content determined by proton magnetic resonance spectroscopy (1H MRS).

Secondary Outcome Measures

Name	Time	Method
Total Adipose Tissue	6 months	total adipose tissue assessed by MRI scan

Trial Locations

Locations (1)

Endocrinology & Metabolic Medicine, Imperial College; 🇬🇧 London, United Kingdom