Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02152553
Status:
COMPLETED
Last Update Posted:
2021-04-12
First Post:
2014-05-12
Brief Title:
Biomarkers for Glucocorticoids
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
ProteinMetabolite Biomarkers for Glucocorticoid Action an Experimental Trial in Patients With Adrenal Insufficiency
Status:
COMPLETED
Status Verified Date:
2021-04
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:
BIOCORT
Brief Summary:
The investigators have shown that patients with adrenal insufficiency Addisons disease a rare disorder have doubled the expected mortality rate in Sweden despite Standard of Care glucocorticoid GC replacement One of the Swedish population are however receiving GCs for inflammatory diseases but management is empirical and adjusted to underlying disease activity The desired anti-inflammatory therapeutic effects cannot be differentiated from the adverse metabolic osteoporosis obesity diabetes mellitus and immunosuppressive side effects of GC This frequently results in suboptimal GC therapy with adverse effects due to over-dosing or poor efficacy due to under-dosing The primary aim is to identify a biomarker for the metabolic effects of GCs Patients with Addisons disease completely lack endogenous GCs and can therefore be considered a human GC knock-out model They can therefore be studied during near-physiological exposure and during GC starvation This will uniquely allow a very clean biomarker identification model using transcriptomics proteomics and metabolomics The secondary aim is to validate candidate biomarkers in a dose-response study using the same patient population A biomarker of GC actions will make it possible to individualised therapy during pharmacological GC treatment It would allow GC replacement to be monitored in Addisons disease and could become a specific diagnostic tool in patients with GC deficiency and excess Cushings syndrome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None