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The Prevalence of Secondary Adrenal Insufficiency in Patients With Exacerbation of COPD in Glucocorticoid Treatment Related to Differenct Gene Polymorphisms of the Glucocorticoid Receptor Gene

NCT03140761 — Completed, 78 participants, Chronic Obstructive Pulmonary Disease Trial Network, Denmark

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RegistryNCT03140761
StatusCompleted
Study typeObservational
Enrollment78 (Actual)
SponsorChronic Obstructive Pulmonary Disease Trial Network, Denmark (Other); collaborators: Copenhagen University Hospital, Rigshospitalet
ConditionsAdrenal Insufficiency
Datesstart 2017-08-17, primary completion 2020-01-01, completion 2020-05-09, first posted 2017-05-04, last updated 2020-05-12
Locations1 site in Denmark

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-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 prevalence of secondary adrenal insufficiency in glucocorticoid-treated patients with exacerbation of COPD.

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+Detailed description

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 patients with acute exacerbation of COPD (AECOPD) at risk of of secondary adrenal insufficiency.

+Outcome measures

Primary outcomes

  • Secondary Adrenal insufficiency [average 1 month]: test for adrenal function by stimulation test

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 90 Years

Inclusion Criteria:

* Adult patients > 18 years
* Caucasian classified with COPD
* Patients with AECOPD being treated with at least 5 days of glucocorticoid (minimum of 180 mg)

Exclusion Criteria:

* Treated with estrogen-containing medications, including anticonceptiva 6 weeks prior to Synacthen®
* Pregnancy or lactation
* on regular systemic glucocorticoid therapy before admission to the hospital
* People who are detained under the act on the use of coercion in psychiatry
* Severe language problems or inability to provide written informed consent

+Locations (1)

FacilityCityCountryStatus
Department of Internal medicine, Herlev & Gentofte Universtity HospitalHellerupDenmark

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