The Effect of Growth Hormone Replacement on Liver Fat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774579
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : June 8, 2015
Novo Nordisk A/S
Information provided by (Responsible Party):
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.

Condition or disease
Growth Hormone, Recombinant Fatty Liver

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 Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat.
Study Start Date : March 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : October 2009

Patients with growth hormone (GH) deficiency starting GH replacement.
Patients with growth hormone (GH) deficiency not starting GH replacement.

Primary Outcome Measures :
  1. liver fat [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. inflammatory markers [ Time Frame: 6 months ]
  2. whole body fat [ Time Frame: 6 months ]
  3. intramuscular fat [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
plasma, serum, leucocytes, 24-hour urine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be recruited from the endocrine clinics of Imperial College Healthcare NHS Trust.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774579

United Kingdom
Endocrinology & Metabolic Medicine, Imperial College
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Novo Nordisk A/S
Study Chair: Fabian A Meienberg, Dr Imperial College London
Study Chair: Stephen Robinson, Dr Imperial College London
Study Chair: Jeremy Cox, Dr Imperial College London
Study Chair: Ian Godsland, Dr Imperial College London
Study Chair: Jimmy Bell, Dr Imperial College London
Principal Investigator: Desmond G Johnston, Prof Imperial College London
Study Chair: Simon Taylor-Robinson, Prof Imperial College London
Study Chair: Emma Hatfield, Dr Imperial College London
Study Chair: Michael Yee, Dr Imperial College London

Responsible Party: Imperial College London Identifier: NCT00774579     History of Changes
Other Study ID Numbers: GHD1
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: December 2009

Keywords provided by Imperial College London:
growth hormone
growth hormone deficiency
liver fat
liver steatosis
growth hormone replacement

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs