Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309498
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-03-07
Brief Title:
Residual Adrenal Function in Addisons Disease
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Residual Adrenal Function in Addisons Disease
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADD-RES
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
11-deoxycortisol levels will be assessed in all recruited patients
Detailed Description:
Addisons 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 nmolL
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 Addisons disease have been described
Recent evidence shows that 5-30 of Addisons 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 patients 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 egSynacthen Test
Despite the pharmacological approach actually Addisons patients have an impaired quality of life For the AI treatment in adults the Endocrine European Societys 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 Addisonians 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 Addisons patient evaluation
Actually diagnosis is based either on low basal cortisol levels or cortisol levels after Synacthen test 250 mcg 500 nmolL
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 Addisons disease have been described
Recent evidence shows that 5-30 of Addisons 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 patients 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 egSynacthen Test
Despite the pharmacological approach actually Addisons patients have an impaired quality of life For the AI treatment in adults the Endocrine European Societys 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 Addisonians 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 Addisons patient evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None