Clinical Trial: The Occurence of Secondary Adrenal Insufficiency in Hospitalised Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational [Patient Registry]

Official Title: The Occurence of Secondary Adrenal Insufficiency in Hospitalised Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor

Brief Summary: To investigate the correlation between four well-known polymorphisms of the glucocorticoid receptor gene (two with reduced sensitivity versus two with increased sensitivity) and the occurrence of secondary adrenal insufficiency in glucocorticoid-treated hospitalised patients with exacerbation of COPD.

Detailed Summary: COPD patients who have received systemic glucocorticoid exceeding the equivalent of 180 mg prednisolone which are homo / heterozygous for the BclI and / or N363S polymorphisms (associated with increased glucocorticoid sensitivity) will have a lower cortisol response in a synacthen® test (greater suppression of adrenal corticosteroid) than the corresponding patients there are wild-type or homo- or heterozygous for the polymorphic ER22 / 23EK and / or 9β (associated with decreased sensitivity). Information from the results of the investigation will be able to help clinicians to identify AECOPD patients at risk of of adrenal insufficiency.
Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Current Primary Outcome: Adrenal insufficiency [ Time Frame: average 1 month ]

test for adrenal function by stimulation test


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Metabolic syndrome [ Time Frame: average 1 month ]
    blood lipids, blood pressure, plasma glucose, abdominal obesity, body composition
  • Bone mineral loss [ Time Frame: average 1 month ]
    bonemarkers
  • Onset of Diabetes Mellitus [ Time Frame: average 1 month ]
  • Quality of life [ Time Frame: average 1 month ]
    test by questionnaires


Original Secondary Outcome: Same as current

Information By: Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Dates:
Date Received: April 17, 2017
Date Started: May 2017
Date Completion: December 2018
Last Updated: May 2, 2017
Last Verified: May 2017