Hypopituitary Adults Clinical Trial
Large population studies of hypopituitary adults (patients with pituitary gland failure) on
conventional hormone replacement, but not growth hormone, have an approximate two fold
increase in death rate (mortality). The vast majority of this excess mortality relates to
vascular disease. While it is possible that overreplacement with steroids, underreplacement
with thyroid hormones and sex hormone deficiency contribute, there are increasing data to
support a role for GH in the cause of the excess vascular risk. Although a number of
surrogates of vascular risk are described in patients with GH deficiency (GHD), how these
translate mechanistically into atherothrombotic (blockage of the arteries) disease has not
been fully elucidated.
This proposed study will analyse both traditional (body composition, serum lipids, handling
of sugars)and more complex markers (inflammation, procoagulation, fibrinolysis) of vascular
risk/disease. In addition the study will examine 24hr blood pressure, arterial wall
thickness, clot structure and function, as well as platelet action. Measurements will be
performed at baseline and will be reassessed after patients have been on a stable dose of GH
replacement for at least three months.
The results of the study will characterise risk factors for vascular disease, and take this a
step further to elucidate how these changes translate mechanistically in to vascular damage.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | July 30, 2020 |
| Est. primary completion date | July 30, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 16 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Able to give written consent - Adults with confirmed GHD (Insulin stimulation test <3ug/L) - Other hormone replacement therapy stable for at least three months Exclusion Criteria: - active malignancy - an acute vascular event within three months of the study - any therapy other than hormone replacement - serum creatinine >120 micromol/l - abnormal LFTs (ALT>3 fold upper limit of normal) |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | The Leeds Teaching Hospital NHS Trust | Leeds |
| Lead Sponsor | Collaborator |
|---|---|
| The Leeds Teaching Hospitals NHS Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Turbidity analysis. | up to 3 years |