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

NCT02049671 | Unknown

• 2 other identifiers: ED12/1039113/YH/0061
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypopituitary Adults

Outcome Measures

Primary Outcomes (1)

• Turbidity analysis.

  up to 3 years

Study Arms (2)

Growth Hormone Therapy

Drug: Growth Hormone Therapy

Control Group

Interventions

Growth Hormone Therapy DRUG

Growth Hormone Therapy

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypopituitary adults

You may qualify if:

• Able to give written consent
• Adults with confirmed GHD (Insulin stimulation test \<3ug/L)
• Other hormone replacement therapy stable for at least three months

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

The Leeds Teaching Hospital NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

Central Study Contacts

Robert Murray, MB;BS, BSc, MD, FRCP

CONTACT

01132064578; robert.murray@leedsth.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 30, 2014
• Study Start: June 1, 2013
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

GB (1)