GAMBOL Study
Research type
Research Study
Full title
The effects of Growth hormone treatment discontinuation in Adults on Metabolic profile, Body composition and quality Of Life (GAMBOL Study)
IRAS ID
305902
Contact name
Sherwin Criseno
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Duration of Study in the UK
2 years, 9 months, 3 days
Research summary
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.REC name
Wales REC 1
REC reference
23/WA/0105
Date of REC Opinion
12 Apr 2023
REC opinion
Favourable Opinion