Glucose regulation and cardiovascular disease in secondary/tertiary AI
Research type
Research Study
Full title
Glucose regulation and cardiovascular health in children with secondary/tertiary adrenal insufficiency (GRACE 2)
IRAS ID
302412
Contact name
Julie Park
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 21 days
Research summary
Hydrocortisone treatment is used to replace low levels of cortisol in patients with adrenal insufficiency (AI). Levels of cortisol are higher than expected immediately following a dose of hydrocortisone and lower than expected prior to the next dose. This pattern may contribute to the increased prevalence of heart disease reported in patients with AI. Direct relationships between hydrocortisone dose, heart health and blood pressure have been reported. It may also contribute to glucose levels that are higher or lower than would be expected. Low blood glucose levels have been reported in adults. Patients are at increased risk of obesity, insulin resistance, abnormal cholesterol levels and impaired glucose regulation. The severity has been related to the total hydrocortisone dose and duration of treatment.
Aims and objectives
To describe blood glucose and blood pressure (BP) profiles, and potential biochemical and vascular mechanisms of disruption to:
(1) Report the prevalence, frequency and severity of high blood glucose levels
(2) Examine associations between BP, cortisol hormone levels, and determinants of cardiovascular risk to identify potential treatment targets
Children with low levels of cortisol, secondary to problems with their pituitary gland (gland in the brain), who are treated with hydrocortisone are eligible. The study will be performed at Alder Hey Children's hospital.
The participants will attend for blood tests, ultrasound scans of their arm and neck, saliva samples for one day, blood pressure monitoring for 24 hours (if old enough) and have a glucose monitor inserted. The glucose monitor will remain in situ for seven days. The participant will not know their blood glucose levels in real time. The results will be discussed with them once the monitor is returned after seven days. The study will last seven days, in total, for each participant.REC name
London - Queen Square Research Ethics Committee
REC reference
21/PR/1163
Date of REC Opinion
25 Oct 2021
REC opinion
Further Information Favourable Opinion