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The Effect of Growth Hormone Replacement on Liver Fat

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

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
Growth Hormone, Recombinant
Fatty Liver

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat.

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • liver fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

plasma, serum, leucocytes, 24-hour urine


Estimated Enrollment: 30
Study Start Date: March 2008
Study Completion Date: October 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with growth hormone (GH) deficiency starting GH replacement.
2
Patients with growth hormone (GH) deficiency not starting GH replacement.

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774579

Locations
United Kingdom
Endocrinology & Metabolic Medicine, Imperial College
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Novo Nordisk
Investigators
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
  More Information

No publications provided

Responsible Party: Prof Desmond G Johnston, Imperial College London
ClinicalTrials.gov Identifier: NCT00774579     History of Changes
Other Study ID Numbers: GHD1
Study First Received: October 16, 2008
Last Updated: December 18, 2009
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Dwarfism, Pituitary
Fatty Liver
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013