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

Tracking Information

First Received Date ^ICMJE

October 16, 2008

Last Updated Date

December 18, 2009

Start Date ^ICMJE

March 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

liver fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00774579 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effect of Growth Hormone Replacement on Liver Fat

Official Title ^ICMJE

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

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.

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 ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

plasma, serum, leucocytes, 24-hour urine

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Growth Hormone, Recombinant
Fatty Liver

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00774579

Other Study ID Numbers ^ICMJE

GHD1

Has Data Monitoring Committee

Responsible Party

Prof Desmond G Johnston, Imperial College London

Study Sponsor ^ICMJE

Imperial College London

Collaborators ^ICMJE

Novo Nordisk

Investigators ^ICMJE

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

Information Provided By

Imperial College London

Verification Date

December 2009

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

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