Fatty Liver Clinical Trial
Official title:
Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat.
NCT number | NCT00774579 |
Other study ID # | GHD1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2008 |
Est. completion date | October 2009 |
Verified date | December 2009 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Endocrinology & Metabolic Medicine, Imperial College | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Novo Nordisk A/S |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intrahepatocellular Lipid (IHCL) Content | IHCL content determined by proton magnetic resonance spectroscopy (1H MRS). | 6 months | |
Secondary | Total Adipose Tissue | total adipose tissue assessed by MRI scan | 6 months |
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