Hypothalamic hormone deficiencies and quality of life
Research type
Research Study
Full title
The relationship between hormone deficiencies in hypopituitary patients and measures of quality of life.
IRAS ID
161451
Contact name
Gerry Leonard
Contact email
Sponsor organisation
Queen Mary, University of London
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Research Summary:
Quality of life (QoL) is impaired in patients with an underactive pituitary gland. The hypothalamic area of the brain is intimately associated with the pituitary and is often damaged in pituitary disorders. This study will investigate the importance of hypothalamic hormone deficiency in poor QoL in this patient group.
Oxytocin is a hormone, produced in the hypothalamus, which has an important role in the formation of social bonds and promoting feelings of trust and affiliation. Melatonin, a brain hormone whose release is controlled by the hypothalamus, forms part of the system that regulates the sleep–wake cycle. Disturbed sleep is strongly associated with daytime fatigue and poor QoL.
The need to pass urine during the night is common in this patient group, as many lack the hormone necessary to concentrate urine. Consequently, disturbed sleep can contribute to daytime mental and physical fatigue. Copeptin, forms part of the hormone system that concentrates urine. The utility of copeptin measurement in detecting urinary concentrating problems, in pituitary patients, is also worthy of analysis.
This study will measure blood levels of oxytocin, copeptin and urine by-products of melatonin in a large group of patients with an underactive pituitary gland. The relationship between these hormone levels and QoL will be assessed by asking study participants to complete questionnaires about various aspects of QoL (eg social interactions, feelings of sadness and isolation, levels of fatigue etc). The results will be compared to a control group of patients, who will undergo the same tests. All tests will be performed during the patient’s and control subject’s routine hospital visits for normal clinical care.
The association between these hormone levels and QoL may yield new insights into an unmet need regarding hormone deficiency in these patients. It will also direct efforts at reducing distress for patients with an underactive pituitary gland.Lay summary of study results:
Patients with hypopituitarism often report poor quality of life despite adequate hormonal replacement therapy. Oxytocin, a peptide hormone produced in the hypothalamus and released by the posterior pituitary, has been known for its role in social and emotional behaviour. Our aim was to look at brain hormones reported to have roles in social behavour and emotions (which are not usually replaced in clinical practice), including oxytocin, copeptin and melatonin and to see if these relate to measure of quality of life in patients with hypopituitarism using otherwise optimal hormonal replacement therapy.We recruited patients with underactive pituitary disease on hormone replacements from our out-patient clinic between 2016 and 2018. The research protocol included fasting blood tests to assess oxytocin and copeptin levels plus an overnight urine collection to analyse melatonin. Quality of life was evaluated using validate questionnaires such as the Short Form Survey (SF-36), Questions on Life Satisfaction-Hypopituitarism (QLS-H), UCLA Loneliness Scale, and Hospital Anxiety and Depression Scale. Patients were compared to matched controls without pituitary disease.
Data were available for 30 patients and 16 controls - we were able to recruit far fewer controls than we had hoped. The two groups were well matched for age, gender and weight. There were no measurable differences in oxytocin or copeptin between the two groups (although there was a trend towards lower oxytocin in patients compared to controls) and too few participants (particularly controls) completed their urine collection to allow good comparisons of melatonin levels. Among our patients, we observed a linear relationship between serum oxytocin and the initiative/drive domain measured by QLS-H.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0233
Date of REC Opinion
4 Feb 2015
REC opinion
Favourable Opinion