Glucose Regulation & CVS studies in Primary Adrenal Insufficiency
Research type
Research Study
Full title
A study of cardiovascular health and glucose regulation in children with adrenal insufficiency: Prevalence of vascular dysfunction and hypoglycaemia and potential therapeutic targets
IRAS ID
283402
Contact name
Joanne Blair
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Patients with adrenal insufficiency (AI) do not make enough cortisol (a chemical messenger in the blood). Cortisol gives us energy, helps us fight infection and helps to control our blood pressure and metabolism. It is important for cardiovascular health (the health of our heart and blood vessels). Children with AI receive hydrocortisone treatment. It is difficult to mimic what our body naturally does with the medication that is currently available.
There are concerns of nocturnal hypoglycaemia (low blood glucose levels at night) because of low levels of cortisol overnight. It is possible that recurrent hypoglycaemia contributes to impaired short-term memory, cognition and quality of life (QoL) reported in paediatric AI patients, and that successful treatment may improve QoL and cognitive outcomes. The risk ratio for death in adult patients with primary AI is more than double the background population, due in part, to an excess of cardiovascular death. We will assess endothelial dysfunction (ultrasound findings in the arm and neck) and blood pressure to assess if there is an indication of early disease, which will enable us to improve outcomes by addressing risk factors at a young age.
Children will attend for their annual review bloods (part of routine care). We will take an extra 1-2 ml. We will give them a glucose monitor to measure their blood glucose for 7 days and a blood pressure monitor for 24 hours. They will keep a diary of their hydrocortisone medications, illness, and exercise. Two hourly daytime salivary samples will be required for cortisol levels. We will perform ultrasound scans of their neck and arm to assess endothelial dysfunction.
This study is funded by Hugh Greenwood Charity. Recruitment will take place at Alder Hey Children’s Hospital. The children will be seen on the Clinical Research Facility at this location.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0301
Date of REC Opinion
10 Aug 2020
REC opinion
Further Information Favourable Opinion