NCT03140761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 17, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

2.4 years

First QC Date

April 17, 2017

Last Update Submit

May 9, 2020

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Secondary Adrenal insufficiency

    test for adrenal function by stimulation test

    average 1 month

Secondary Outcomes (4)

  • Metabolic syndrome

    average 1 month

  • Bone mineral loss

    average 1 month

  • Onset of Diabetes Mellitus

    average 1 month

  • Quality of life

    average 1 month

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

78 hospitalised patients with exacerbation of COPD

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal medicine, Herlev & Gentofte Universtity Hospital

Hellerup, 2900, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and DNA from gene analyses

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Phd fellow

Study Record Dates

First Submitted

April 17, 2017

First Posted

May 4, 2017

Study Start

August 17, 2017

Primary Completion

January 1, 2020

Study Completion

May 9, 2020

Last Updated

May 12, 2020

Record last verified: 2020-05

Locations

DK(1)