The Effect of Growth Hormone Replacement on Liver Fat

April 29, 2019 updated by: Imperial College London

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W2 1NY
        • Endocrinology & Metabolic Medicine, Imperial College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Patients with growth hormone (GH) deficiency starting GH replacement.
2
Patients with growth hormone (GH) deficiency not starting GH replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrahepatocellular Lipid (IHCL) Content
Time Frame: 6 months
IHCL content determined by proton magnetic resonance spectroscopy (1H MRS).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Adipose Tissue
Time Frame: 6 months
total adipose tissue assessed by MRI scan
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Novo Nordisk A/S

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (Estimate)

October 17, 2008

Study Record Updates

Last Update Posted (Actual)

July 12, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHD1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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