Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Risk of Adrenal Insufficiency and Cushing Syndrome Associated With Glucocorticoid Therapy in People With Chronic Inflammatory Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575247
Recruitment Status : Completed
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mar Pujades Rodriguez, University of Leeds

Brief Summary:

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. Although glucocorticoids are effective in controlling disease symptoms, continuous use of the drugs can lead to suppression of adrenal hormones or excessive cortisol level in the blood stream. That is, excess blood cortisol level due to glucocorticoid exogenous supply can either inhibit the 'hypothalamus-pituitary-adrenal axis' for adrenal hormones production or result in Cushing symptoms.

In the period between 1989 and 2008 in the UK, it was estimated that 0.6%-0.8% of the general adult population were long-term users of oral glucocorticoids. However, there is no data on the risk of adrenal suppression and Cushing syndrome due to chronic use of glucocorticoids in the UK to date.

The aim of the study is to investigate the risk of adrenal insufficiency and Cushing syndrome due to long-term use of glucocorticoids in England.


Condition or disease Intervention/treatment
Adrenal; Insufficiency Gluccorticoid-Induced Cushing; Syndrome or Disease, Glucocorticoid-Induced Drug: Glucocorticoids

Detailed Description:

Adrenal insufficiency is a clinical condition that is associated with a deficiency of adrenal hormones, mainly: glucocorticoids and mineralocorticoids. Cushing syndrome is also a condition that stems from the existence of persistent high cortisol level in the body. The majority of Cushing syndrome cases are exogenous (iatrogenic or due to use of medication).

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. Although glucocorticoids are effective in controlling disease symptoms, continuous use of the drugs can lead to suppression of adrenal hormones or excessive cortisol level in the blood stream. That is, excess blood cortisol level due to glucocorticoid exogenous supply can either inhibit the 'hypothalamus-pituitary-adrenal axis' for adrenal hormones production or result in Cushing symptoms.

In the period between 1989 and 2008 in the UK, it was estimated that 0.6%-0.8% of the general adult population were long-term users of oral glucocorticoids. However, there is no data on the risk of adrenal suppression and Cushing syndrome due to chronic use of glucocorticoids in the UK to date

The aim of the study is to investigate the risk of adrenal insufficiency and Cushing syndrome due to long-term use of glucocorticoids in England. This is a retrospective cohort study of people diagnosed with at least one of six chronic inflammatory diseases (polymialgia rheumatica, giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, vasculitis and inflammatory bowel disease).

This study will be based on the analysis of existing primary care health records routinely collected, linked to hospital and mortality data.


Layout table for study information
Study Type : Observational
Actual Enrollment : 111804 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Risk of Adrenal Insufficiency and Cushing Syndrome Associated With Glucocorticoid Therapy in People With Chronic Inflammatory Diseases
Actual Study Start Date : January 1, 1998
Actual Primary Completion Date : January 30, 2015
Actual Study Completion Date : September 30, 2015



Intervention Details:
  • Drug: Glucocorticoids
    Long-term use of glucocorticoids


Primary Outcome Measures :
  1. Glucocorticoid-related adrenal insufficiency [ Time Frame: 18 years ]
    First recorded diagnosis of adrenal insufficiency

  2. Glucocorticoid-related Cushing syndrome [ Time Frame: 18 years ]
    First recorded diagnosis of Cushing syndrome


Secondary Outcome Measures :
  1. All cause mortality [ Time Frame: 18 years ]
    Recorded death of any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients registered in CPRD who were eligible for data linkage and had been diagnosed with at least one of six chronic inflammatory diseases (inflammatory bowel diseases, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, rheumatoid arthritis, and vasculitis) in the period between 1st Jan 1998 and 30th September 2015.
Criteria

Inclusion Criteria:

  • Patients aged 18 years old or over
  • Registered in a participating general practice for more than 1 year during the study period
  • Minimum of 1 year prior to study entry meeting CPRD data quality
  • Diagnosed with at least one of the 6 chronic inflammatory diseases

Exclusion Criteria:

  • Patients aged under 18 years during the study period
  • Registered in general practices that did not consent to data linkage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575247


Sponsors and Collaborators
University of Leeds
Investigators
Layout table for investigator information
Principal Investigator: Mar Pujades-Rodriguez, PhD University of Leeds

Layout table for additonal information
Responsible Party: Mar Pujades Rodriguez, University Academic Fellow, University of Leeds
ClinicalTrials.gov Identifier: NCT03575247     History of Changes
Other Study ID Numbers: 16_146
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Adrenal Insufficiency
Cushing Syndrome
Syndrome
Disease
Pathologic Processes
Adrenal Gland Diseases
Endocrine System Diseases
Adrenocortical Hyperfunction
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs