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Clinical Trials/NCT06309498
NCT06309498RecruitingNot Applicable

Residual Adrenal Function in Addison's Disease

Istituto Auxologico Italiano1 site in 1 country50 target enrollmentStarted: January 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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