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Status unknownNCT02049671Updated Aug 19, 2019

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

An observational study in Hypopituitary Adults, sponsored by The Leeds Teaching Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 16 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-08-19.

Sponsored by The Leeds Teaching Hospitals NHS Trust · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
16 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypopituitary Adults
03

In context

Lead sponsor

The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Hypopituitary adults

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Growth Hormone Therapy

    Drug: Growth Hormone Therapy

  • Control Group

Interventions

  • DrugGrowth Hormone Therapy
06

What researchers measure

Primary outcomes

  1. Turbidity analysis.

    Time frame: up to 3 years

07

Study locations

1 of 1 sites recruiting
  • The Leeds Teaching Hospital NHS Trust
    Leeds, LS9 7TF, United Kingdom
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02049671
Lead sponsor
The Leeds Teaching Hospitals NHS Trust
Responsible party
Sponsor
First posted
Jan 30, 2014
Start date
Jun 1, 2013
Primary completion
Jul 30, 2020 (estimated)
Completion
Jul 30, 2020 (estimated)
Last update
Aug 19, 2019

Study contacts

Robert Murray, MB;BS, BSc, MD, FRCP
Contact
robert.murray@leedsth.nhs.uk
01132064578
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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