This pilot study is designed to compare healthy volunteers with three groups of patients with adrenal insufficiency and a final group of patients receiving high dose steroids for anti-inflammatory purposes. The study will collect data on all 5 groups with the intention of identifying any novel markers or immunological indicators which may be used clinically to gauge the adequacy of steroid replacement treatment in patients with adrenal insufficiency.
Glucocorticoid replacement in adrenal insufficiency poses a significant challenge. If given too much, patients risk long term complications including diabetes, osteoporosis and cardiovascular disease. If, however they are given too little, patients can feel tired, unwell and may collapse as there is insufficient steroid hormone to cope with stress. Currently there is no single objective marker or outcome that can be measured to ascertain whether a patient is receiving optimum glucocorticoid replacement therapy. This study will investigate a selection of markers to examine whether they can be used to as indicators to gauge the adequacy of therapy. Finding an appropriate marker could unlock better care and outcomes for our patients with adrenal insufficiency .
Study Type
OBSERVATIONAL
Enrollment
100
Imperial College Healthcare NHS Trust
London, United Kingdom
RECRUITINGOsteocalcin
Assesses bone health of each group by comparing total osteocalcin and undercarboxylated osterocalcin
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
P1NP
Assesses bone health of each group by comparing P1NP
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
NTX
Assesses bone health of each group by comparing NTX
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Heart Rate
recording observations- heart rate
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Blood pressure
recording observations- blood pressure
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Waist-Hip circumference
recording observations- Waist-Hip circumference ratios
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Lipid profile (Total cholesterol, HDL, LDL and triglycerides)
measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides
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Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
High sensitivity CRP
measuring biochemical indicators of cardiovascular risk: high sensitivity CRP
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Glucose
measuring glucose
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
HbA1c
measuring HbA1c
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Infection rates and severity
assessed by completion of the German National Cohort Questionnaire (GNCQ), questionnaires will cover socio-economic and socio-demographic factors, medical history, use of medications and health care, lifestyle factors, and questions related to environmental and occupational factors
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.
Wellbeing
the short form health survey-36 (SF-36)
Time frame: Single time point for controls. Steroid replacement patients will have been on at least 4 months of stable therapy.