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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Sherwin
Criseno
Sherwin.criseno@uhb.nhs.uk
Sherwin
Criseno
Sherwin.criseno@uhb.nhs.uk
Disorders of other endocrine glands
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Treatment with recombinant human growth hormone (GH) injection in adult patients with growth hormone deficiency (GHD) has been shown to improve some of the health related issues associated with the condition. However, to date, no randomised control trial (RCT) has consistently demonstrated that GH treatment has a sustained beneficial effect on adults with GHD. This, therefore, raises several questions regarding the benefits and risks associated with long-term GH treatment in adults. Currently, there are no guidelines informing the optimal duration of GH therapy in adults. As a result, GH is prescribed indefinitely without clear evidence on the benefits of long-term treatment.
This study will explore the current practice of offering discontinuation of long-term GH treatment in adults in the UK and assess the feasibility of conducting a large-scale multi-centre study looking at the effects of discontinuing long-term GH treatment on the metabolic profile, body composition and quality of life in adults with GHD.
This is a mixed-method study which will be conducted in three phases over 40 months.
Phase 1: Survey of endocrine clinicians to ascertain the current practice of offering discontinuation of long-term GH therapy in adult patients with GHD. (Ethic approval is not required for Phase 1. Details are for information only.)
Phase 2: Interventional feasibility cohort study will involve recruiting adult patients with GHD
(aged 25 years and over), who have been on GH treatment for at least 5 years. This will involve (a) a discontinuation group with 20-25 patients who are willing to discontinue their long-term GH treatment for 2 years and (b) a continuation group with 20-25 patients who agree to be monitored according to the study protocol whilst continuing their GH treatment.
Phase 3: Qualitative study involves semi-structured interviews, undertaken in person or by phone to explore patients' view about taking part in the study.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Management of Care;
You can take part if:
You may not be able to take part if:
Phase 1 (Online survey) (Ethic approval is not required for this phase of the GAMBOL study. Details are provided for information purposes only.) - None Phase 2 (Feasibility study) - Patients with poorly controlled diabetes (defined as having a HbA1c of > 7%), poorly controlled hyperlipidaemia and severe cardiovascular disease. - Patients receiving treatment for low BMD or deemed to be requiring treatment for low BMD during baseline screening. - Patients who are unable to provide informed written consent. Phase 3 (Interview) - None
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by UNIVERSITY HOSPITALS BIRMINGHAM NHS FOUNDATION TRUST and funded by NIHR Academy .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 55747
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