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

Completed

• Conditions: Adrenal Insufficiency

• Registration Number: NCT03140761
• Lead Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark

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

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.

Study Timeline

• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Study Start: 2017-08-17
• Primary Completion: 2020-01-01
• Status Verified: 2020-05
• Study Completion: 2020-05-09
• Last Update Submitted: 2020-05-09
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Adrenal insufficiency	average 1 month	test for adrenal function by stimulation test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Internal medicine, Herlev & Gentofte Universtity Hospital; 🇩🇰 Hellerup, Denmark