Effects of stopping growth hormone treatment in adults with deficiency
The Effects of Growth Hormone Treatment Discontinuation in Adults on Metabolic Profile, Body Composition and Quality Of Life
This study looks at how stopping growth hormone treatment affects adults with growth hormone deficiency after they've been on it for at least five years, focusing on their health, body changes, and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 25 Years to 90 Years |
| Sex | All |
| Sponsor | University Hospital Birmingham Academic / other |
| Locations | 1 site (Birmingham, West Midlands) |
| Trial ID | NCT05979480 on ClinicalTrials.gov |
What this trial studies
This observational study examines the impact of discontinuing growth hormone (GH) treatment in adults diagnosed with growth hormone deficiency (GHD). It aims to assess changes in metabolic profile, body composition, and quality of life after patients have been on GH replacement therapy for at least five years. The study utilizes dual energy X-ray absorptiometry (DXA) to evaluate body composition and other health metrics. By analyzing these factors, the research seeks to provide insights into the long-term effects of GH treatment cessation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 25 years and older who have been diagnosed with GHD and have been on GH replacement therapy for five years or longer.
Not a fit: Patients with poorly controlled diabetes, hyperlipidaemia, severe cardiovascular disease, or those requiring treatment for low bone mineral density may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the optimal duration of GH treatment and improve management strategies for adults with GHD.
How similar studies have performed: While there have been short-term studies on GH treatment, this study's focus on long-term effects of treatment discontinuation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, West Midlands
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, West Midlands, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Mr Criseno
- Email: Sherwin.criseno@uhb.nhs.uk
- Phone: 00441213716950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.