- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06309498
Residual Adrenal Function in Addison's Disease (ADD-RES)
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
Study Overview
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.
The clinical significance of this RAF is unknown but potentially can reduce the need of hormone replacement, affecting the patient's quality of life. An approach to determine residual endogenous cortisol production may be the measurement of its precursor, 11-deoxycortisol (11DOC).
The main aim of this study is to assess the role of 11DOC as surrogate marker of RAF.
It is expected that 15% of our population have a RAF. In patients with RAF we expect significantly higher 11DOC values and at the same time a lower prevalence of Addisonian crisis with a higher prevalence of complications as diabetes mellitus, arterial hypertension, osteoporosis and infections caused by the overtreatment.
Meanwhile, in patients without RAF a higher rate of Addisonian crisis despite a higher dose of treatment is expected.
The possibility to map the RAF in patients on hydrocortisone substitutive therapy by the use of a single marker (11DOC) could be useful as it permits to have a more patient- based medical approach without having to carry out time consuming tests (e.g.Synacthen Test).
Despite the pharmacological approach actually Addison's patients have an impaired quality of life. For the AI treatment in adults, the Endocrine European Society's recommended daily glucocorticoid replacement dose (DGRD) is 15 to 25 mg hydrocortisone. Under-replacement may result in weight loss, hypotension, hyponatremia, and death. In contrast, glucocorticoids excess may cause metabolic complications and immune suppression.
If this hypothesis were confirmed it could be helpful to reduce the DGRD in patients with RAF, in order to minimize the incidence of complication of long-term therapy. On the other side, in patients without RAF, it could be useful to take more attention to reduce the risk of Addisonian's crisis.
Last but not least, finding a marker of RAF, as 11DOC, without having to perform further tests, could allow to reduce timing and costs for the single Addison's patient evaluation.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Valentina Morelli, PhD
- Phone Number: 02619112547
- Email: v.morelli@auxologico.it
Study Contact Backup
- Name: Carmen Aresta, MD
- Phone Number: 02619112547
- Email: c.aresta@auxologico.it
Study Locations
-
-
-
Milan, Italy, 20135
- Recruiting
- Istituto Auxologico Italiano
-
Contact:
- Valentina Morelli
- Phone Number: 02619112547
- Email: v.morelli@auxologico.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Autoimmune Addison's disease
- Informed consent
Exclusion Criteria:
- Drugs affecting immune system or steroids other than hydrocortisone or cortisone acetate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of RAF
Time Frame: baseline
|
residual adrenal function
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prevalence of adrenal crisis
Time Frame: 24 months
|
prevalence of adrenal crisis in relation to RAF
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Valentina Morelli, PHD, Istituto Auxologico Italiano
Publications and helpful links
General Publications
- Pearce SHS, Gan EH, Napier C. MANAGEMENT OF ENDOCRINE DISEASE: Residual adrenal function in Addison's disease. Eur J Endocrinol. 2021 Feb;184(2):R61-R67. doi: 10.1530/EJE-20-0894.
- Vulto A, Bergthorsdottir R, van Faassen M, Kema IP, Johannsson G, van Beek AP. Residual endogenous corticosteroid production in patients with adrenal insufficiency. Clin Endocrinol (Oxf). 2019 Sep;91(3):383-390. doi: 10.1111/cen.14006. Epub 2019 Jun 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05C307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adrenal Insufficiency
-
University Hospital TuebingenCompletedAdrenal InsufficiencyGermany
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingGlucocorticoid-induced Adrenal InsufficiencyFrance
-
Tobias ElseCorcept TherapeuticsTerminatedMifepristone | Central Adrenal InsufficiencyUnited States
-
Assistance Publique Hopitaux De MarseilleTerminatedAdrenocortical InsufficiencyFrance
-
Diurnal LimitedActive, not recruitingPrimary Adrenal InsufficiencyGermany, United Kingdom
-
University of Roma La SapienzaCompletedSecondary Adrenal Insufficiency | Primary Adrenal InsufficiencyItaly
-
Chronic Obstructive Pulmonary Disease Trial Network...Rigshospitalet, DenmarkCompleted
-
Bruno AllolioCompletedPrimary Adrenal InsufficiencyGermany
-
University of BergenKarolinska Institutet; Charite University, Berlin, GermanyActive, not recruitingPrimary Adrenal InsufficiencyNorway, Sweden, Germany
-
University Medical Center GroningenCompletedAdrenal InsufficiencyNetherlands
Clinical Trials on blood test
-
French National Agency for Research on AIDS and...Completed
-
Pascual Gregori RoigHospital Universitario de la Plana; FUNDACIÓN DAVALOS FLETCHERCompletedHyperbilirubinemia, Neonatal | Anemia Neonatal | Polycythemia SecondarySpain
-
Wingate InstituteTel Aviv UniversityCompleted
-
University Hospital, ToursCompleted
-
Cairo UniversityUnknownClass III Malocclusion | Class II Malocclusion
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Imperial College LondonCompletedHereditary Hemorrhagic Telangiectasia | Pulmonary Arteriovenous MalformationsUnited Kingdom
-
Minovia Therapeutics Ltd.RecruitingMyelodysplastic SyndromesIsrael
-
Centre Hospitalier Universitaire de NīmesRecruitingNeoplasm Metastasis | Colorectal Cancer | Disseminated CancerFrance
-
University Hospital, GenevaHospices Civils de LyonNot yet recruitingAbuse, Child | Protein Disorder, BloodFrance, Switzerland