Hypopituitary AdultsNCT02049671
Elucidation of the Effects of Growth Hormone (GH) Deficiency and GH Replacement on Clot and Platelet
An observational study of Hypopituitary Adults, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Hypopituitary Adults
- What is being tested?
- Growth Hormone Therapy
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2013to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- Child, Adult, Older adult
Study population: Hypopituitary adults
Who may be able to join
- Able to give written consent
- Adults with confirmed GHD (Insulin stimulation test <3ug/L)
- Other hormone replacement therapy stable for at least three months
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
The Leeds Teaching Hospital NHS Trust
Leeds, LS9 7TF
Robert Murray, MB;BS, BSc, MD, FRCP, 01132064578, robert.murray@leedsth.nhs.uk
About this study
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
- Being tested
- Growth Hormone Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Hormone TherapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone Therapy | Not described Receives: Drug: Growth Hormone Therapy | |
| Control Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turbidity analysis.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study start1 Jun 2013
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypopituitary AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049671
- Sponsor's protocol ID
- ED12/10391
- Other IDs
- 13/YH/0061
- Status last verified
- Aug 2019
- First submitted
- 20 Jan 2014
- Last updated
- 19 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidation of the Effects of Growth Hormone (GH) Deficiency and GH Replacement on Clot and Platelet
- ClinicalTrials.gov ID
- NCT02049671
- Acronym / sponsor ID
- ED12/10391
- Conditions
- Hypopituitary Adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Jun 2013 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth Hormone Therapy | – | Drug: Growth Hormone Therapy |
| Control Group | – | – |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Hypopituitary adults
Key inclusion criteria (3 listed)
- Able to give written consent
- Adults with confirmed GHD (Insulin stimulation test <3ug/L)
- Other hormone replacement therapy stable for at least three months
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth Hormone Therapy | Drug | Growth Hormone Therapy |
Primary outcome
Turbidity analysis.
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypopituitary Adults, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Murray, MB;BS, BSc, MD, FRCP (01132064578, robert.murray@leedsth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turbidity analysis. (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.