The Effects of Growth Hormone Treatment Discontinuation in Adults on Metabolic Profile, Body Composition and Quality Of Life (GAMBOL Study)

Launched by UNIVERSITY HOSPITAL BIRMINGHAM · Jul 28, 2023

Keywords

ClinConnect Summary

The GAMBOL Study is a clinical trial investigating what happens when adults with growth hormone deficiency (GHD) stop their long-term growth hormone (GH) treatment. GHD can cause issues like tiredness, low mood, and weak bones, and many patients wonder if stopping their GH injections will lead to a return of these symptoms. The study aims to see if it's possible to conduct a larger trial comparing the effects of continuing versus stopping GH treatment.

To participate, individuals must be at least 25 years old, have been on GH therapy for five years or longer, and have a confirmed diagnosis of GHD. Those who join will either stop their GH treatment for two years or continue with it, while researchers will monitor their health through blood tests and quality of life surveys. The study will also involve interviews to gather more insights about the participants' experiences. This research is important because it will help answer crucial questions for patients considering the continuation or discontinuation of their GH treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 25 years and over with GHD.
• • GHD previously confirmed by a validated test as per guideline (7).
• • On GH replacement therapy for 5 years or longer.
• • Able to provide informed written consent.
• Exclusion Criteria:
• • Patients with poorly controlled diabetes (defined as having an 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.