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OpenTrials
Completed

NCT Number: NCT03140761

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.

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Key information

Conditions

Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal medicine, Herlev & Gentofte Universtity Hospital

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Secondary Adrenal insufficiency

    Time frame: average 1 month

    test for adrenal function by stimulation test

Secondary outcomes

  1. Metabolic syndrome

    Time frame: average 1 month

    blood lipids, blood pressure, plasma glucose, abdominal obesity, body composition

  2. Bone mineral loss

    Time frame: average 1 month

    bonemarkers

  3. Onset of Diabetes Mellitus

    Time frame: average 1 month

  4. Quality of life

    Time frame: average 1 month

    test by questionnaires

Sponsors and collaborators

Lead sponsor

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 4, 2017
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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