ISRCTN62724177
Active, Not Recruiting
N/A
Clinical validation of a non-invasive diagnostic test for adrenal insufficiency using comparative pharmacodynamic equivalence in a healthy population
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Adrenal insufficiency
- Sponsor
- Sheffield Children's NHS Foundation Trust
- Enrollment
- 32
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current participant inclusion criteria as of 17/11/2023:
- •1\. Healthy men, women and children aged 4\-69 years old
- •2\. Able to comply with passive drool salivary sampling requirements
- •3\. Provision of signed written informed consent
- •Previous participant inclusion criteria:
- •1\. Healthy men, women and children aged 2\-69 years old
- •2\. Able to comply with passive drool salivary sampling requirements
- •3\. Provision of signed written informed consent
Exclusion Criteria
- •1\. Known adrenal insufficiency, Cushing's syndrome or any other adrenal or pituitary gland disorder
- •2\. Ongoing pregnancy
- •3\. Use of oestrogen\-containing hormonal contraception / Hormone Replacement Therapy (due to the effect on cortisol levels)
- •4\. Known condition requiring daily administration of a medication that interferes with the metabolism of glucocorticoids, e.g. known to affect corticosteroid binding globulin (CBG), including all oestrogens, or the hypothalamic\-pituitary\-adrenal (HPA) axis, including opioids, oral antifungals, loperamide
- •5\. Known and active protein losing disorders, e.g. enteropathy or nephrotic syndrome, who may have a cortisol binding globulin abnormality
- •6\. Known clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the upper limit of normal (ULN) or elevated liver function tests (alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the ULN).
- •7\. Participants on regular, inhaled, topical, nasal, ocular, rectal, oral or intra\-articular steroids for any indication in the last 3 months
- •8\. Current uncontrolled active infection
- •9\. BMI \>35 kg/m² (or BMI \>3 standard deviations (SD) above the mean for age and sex if \<16 years)
- •10\. Known or suspected alcohol dependence or drug misuse
Outcomes
Primary Outcomes
Not specified
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