The Effect of Growth Hormone Replacement on Liver Fat

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00774579
First received: October 16, 2008
Last updated: December 18, 2009
Last verified: December 2009

October 16, 2008
December 18, 2009
March 2008
March 2009   (final data collection date for primary outcome measure)
liver fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00774579 on ClinicalTrials.gov Archive Site
  • inflammatory markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • whole body fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • intramuscular fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Growth Hormone Replacement on Liver Fat
Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma, serum, leucocytes, 24-hour urine

Non-Probability Sample

Patients will be recruited from the endocrine clinics of Imperial College Healthcare NHS Trust.

  • Growth Hormone, Recombinant
  • Fatty Liver
Not Provided
  • 1
    Patients with growth hormone (GH) deficiency starting GH replacement.
  • 2
    Patients with growth hormone (GH) deficiency not starting GH replacement.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00774579
GHD1
No
Prof Desmond G Johnston, Imperial College London
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
Imperial College London
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP