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

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.

Study Overview

• Status: Completed
• Conditions: Adrenal Insufficiency

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 Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Department of Internal medicine, Herlev & Gentofte Universtity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

78 hospitalised patients with exacerbation of COPD

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Adrenal insufficiency	test for adrenal function by stimulation test	average 1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
• Collaborators: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2017
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): May 9, 2020

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenal Insufficiency
• Other Study ID Numbers: COPTRIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No