Residual Adrenal Function in Addison's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Istituto Auxologico Italiano
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- prevalence of RAF
Study Overview
Brief Summary
The main aim of this study is to assess the role of 11-deoxycortisol as surrogate marker of Residual adrenal function.
11-deoxycortisol levels will be assessed in all recruited patients
Detailed Description
Addison's disease is an autoimmune disease characterized by inadequate secretion of cortisol and aldosteron by adrenal cortex as a consequence of progressive destruction of the adrenal gland. The absence of specific signs and symptoms could delay the diagnosis and treatment. Considering the importance of these two hormones, a not adequate treatment can result in Addisonian crisis and even be a cause of increased mortality.
Actually, diagnosis is based either on low basal cortisol levels or cortisol levels after Synacthen test (250 mcg) < 500 nmol/L.
Adrenal insufficiency (AI) is most of the time the inevitable end result of the autoimmune process, but some cases of partial recovery of adrenal function in a patient with autoimmune Addison's disease have been described.
Recent evidence shows that 5-30% of Addison's patients, also after many years of disease, maintain a residual endogenous corticosteroid production thanks to a partial adrenal cortex functionality, known as residual adrenal function (RAF).
Indeed, some studies show how the 3-15% of patients have detectable cortisol at Synacthen 250 mcg test, demonstrating that in one third of patients with long-standing disease, some RAF was still present.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Autoimmune Addison's disease
- •Informed consent
Exclusion Criteria
- •Drugs affecting immune system or steroids other than hydrocortisone or cortisone acetate
Outcomes
Primary Outcomes
prevalence of RAF
Time Frame: baseline
residual adrenal function
Secondary Outcomes
- prevalence of adrenal crisis(24 months)
