Trials / Unknown
UnknownNCT02049671
Elucidation of the Effects of Growth Hormone (GH) Deficiency and GH Replacement on Clot and Platelet
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- The Leeds Teaching Hospitals NHS Trust · Academic / Other
- Sex
- All
- Age
- 16 Years – 90 Years
- Healthy volunteers
- —
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Growth Hormone Therapy |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2020-07-30
- Completion
- 2020-07-30
- First posted
- 2014-01-30
- Last updated
- 2019-08-19
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02049671. Inclusion in this directory is not an endorsement.