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Completed

NCT Number: NCT00774579

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.

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Key information

Conditions

Growth Hormone, Recombinant Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Digestive System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Fatty Liver Hypopituitarism Hypothalamic Diseases Liver Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Endocrinology & Metabolic Medicine, Imperial College

London, W2 1NY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intrahepatocellular Lipid (IHCL) Content

    Time frame: 6 months

    IHCL content determined by proton magnetic resonance spectroscopy (1H MRS).

Secondary outcomes

  1. Total Adipose Tissue

    Time frame: 6 months

    total adipose tissue assessed by MRI scan

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 17, 2008
Registry last updated
Jul 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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