Elucidation of the Effects of Growth Hormone (GH) Deficiency and GH Replacement on Clot and Platelet

• Sponsor: The Leeds Teaching Hospitals NHS Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02049671
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 85.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypopituitary Adults	Drug: Growth Hormone Therapy

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Actual Study Start Date: Jun 1, 2013
• Anticipated Primary Completion Date: Jul 30, 2020
• Anticipated Study Completion Date: Jul 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Growth Hormone Therapy	Drug: Growth Hormone Therapy
Control Group

Outcome Measures

Primary Outcome Measures

1. Turbidity analysis. [up to 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 90 Years
• Sexes Eligible for Study: All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Leeds Teaching Hospital NHS Trust	Leeds		United Kingdom	LS9 7TF

Sponsors and Collaborators

• The Leeds Teaching Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Leeds Teaching Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT02049671
• Other Study ID Numbers: ED12/10391; 13/YH/0061
• First Posted: Jan 30, 2014
• Last Update Posted: Aug 19, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Hormones

Study Results

No Results Posted as of Aug 19, 2019