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| Sponsor: | Imperial College London |
|---|---|
| Collaborator: |
Novo Nordisk |
| Information provided by: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00774579 |
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 |
|---|
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Growth Hormone, Recombinant Fatty Liver |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Growth Hormone Replacement in Adults With Growth Hormone Deficiency (GHD) - The Effect on Liver Fat. |
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.
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2
Patients with growth hormone (GH) deficiency not starting GH replacement.
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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 |
Patients will be recruited from the endocrine clinics of Imperial College Healthcare NHS Trust.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United Kingdom | |
| Endocrinology & Metabolic Medicine, Imperial College | |
| London, United Kingdom, W2 1NY | |
| 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
| Responsible Party: | Imperial College London ( Prof Desmond G Johnston ) |
| Study ID Numbers: | GHD1 |
| Study First Received: | October 16, 2008 |
| Last Updated: | December 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00774579 History of Changes |
| Health Authority: | United Kingdom: Research Ethics Committee |
|
growth hormone growth hormone deficiency liver fat liver steatosis growth hormone replacement |
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Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Liver Diseases Pituitary Diseases Physiological Effects of Drugs Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Central Nervous System Diseases |
Fatty Liver Dwarfism, Pituitary Brain Diseases Hormones Bone Diseases Pharmacologic Actions Digestive System Diseases Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental |
