Adrenocortical insufficiency Nutritional, Metabolic, Endocrine
Conditions
Interventions
The method of randomisation is blocked randomisation according to type of adrenal insufficiency (primary versus secondary).
1. Four months of prednisolone once daily followed by 4 months of hydrocorti
Sponsors
Imperial College of Science, Technology and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 – 70 years 2. Male or female 3. Diagnosed with AI for over 6 months according to standard diagnostic criteria 4. Established on stable HC replacement or prednisolone replacement, dose not altered for at least 3 months 5. Established on a stable dose of Fludrocortisone, if taking, dose not altered for at least 3 months 6. Participants taking other hormone replacements (e.g. levothyroxine, testosterone or growth hormone in secondary adrenal insufficiency) are accepted providing that their replacement doses have not altered for at least 3 months 7. Participants who are otherwise healthy enough to participate, as determined by pre-study medical history and physical examination 8. Participants who are able and willing to give written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus 2. Unable to give informed consent 3. Taking supplements or herbal medications that the participant is unwilling or unable to stop prior to and during the study period e.g. St John's Wort (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties) 4. Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the participant is unwilling or unable to stop prior to and during the study period e.g. phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir 5. Pregnancy, taking the oral contraceptive pill, or oral oestrogen replacement therapy due to the effects on cortisol binding globulin levels and determination of prednisolone levels. Transdermal oestrogen replacement is permitted 6. Diagnosis of congenital adrenal hyperplasia, untreated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone health assessed by Osteocalcin concentration at Day 1, Day 30 and Day 120 of each study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bone health assessed by urinary NTX concentration at Day 1, Day 30 and Day 120 of each study period 2. Cardiovascular risk assessed by heart rate at Day 1, Day 30 and Day 120 of each study period 3. Cardiovascular risk assessed by blood pressure at Day 1, Day 30 and Day 120 of each study period 4. Cardiovascular risk assessed by waist-hip circumference at Day 1, Day 30 and Day 120 of each study period 5. Cardiovascular risk assessed by lipid profile (total cholesterol, HDL, LDL and triglycerides) at Day 1, Day 30 and Day 120 of each study period 6. Cardiovascular risk assessed by high sensitivity CRP at Day 1, Day 30 and Day 120 of each study period 7. Glycaemic handling assessed by Glucose at Day 1, Day 30 and Day 120 of each study period 8. Glycaemic handling assessed by HbA1c Day 1, Day 30 and Day 120 of each study period 9. Infection rates and severity assessed by completion of the German National Cohort Questionnaire (GNCQ) at Day 1, Day 30 and Day 120 of each study period 10. Wellbeing assessed by completion of the short form health survey-36 (SF-36) at Day 1, Day 30 and Day 120 of each study period 11. Wellbeing assessed by completion of Addisons Quality of Life questionnaire (AddiQoL) at Day 1, Day 30 and Day 120 of each study period | — |
Countries
England, United Kingdom
Outcome results
None listed