Assessing adrenal function in patients with Addison's disease
Residual Adrenal Function in Addison's Disease
This study is testing whether measuring a specific hormone can help doctors understand how well the adrenal glands are working in people with Addison's disease and if that can improve their treatment and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06309498 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the role of 11-deoxycortisol as a surrogate marker for residual adrenal function in patients with autoimmune Addison's disease. It will involve measuring 11-deoxycortisol levels in recruited patients to determine if any residual endogenous corticosteroid production exists. The study seeks to understand the clinical significance of residual adrenal function, which may impact treatment needs and overall quality of life for patients. By identifying patients with residual function, the study could help tailor hormone replacement therapy more effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with autoimmune Addison's disease who can provide informed consent.
Not a fit: Patients currently taking drugs that affect the immune system or steroids other than hydrocortisone or cortisone acetate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment plans for patients with Addison's disease, potentially reducing the need for hormone replacement therapy.
How similar studies have performed: While some studies have indicated the presence of residual adrenal function in a subset of Addison's patients, this specific approach using 11-deoxycortisol as a marker is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Autoimmune Addison's disease * Informed consent Exclusion Criteria: - Drugs affecting immune system or steroids other than hydrocortisone or cortisone acetate
Where this trial is running
Milan
- Istituto Auxologico Italiano — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Valentina Morelli, PHD — Istituto Auxologico Italiano
- Study coordinator: Valentina Morelli, PhD
- Email: v.morelli@auxologico.it
- Phone: 02619112547
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.