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Predisposing Factors for the Incidence of Adrenal Crisis (PIA)

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ClinicalTrials.gov Identifier: NCT03410160
Recruitment Status : Active, not recruiting
First Posted : January 25, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Wuerzburg University Hospital

Brief Summary:
Within this clinical study patients with chronic adrenal insufficiency will be investigated by clinical and biochemical examination as well as questionnaire to identify predisposing factors for adrenal crisis.

Condition or disease Intervention/treatment
Adrenal Insufficiency Diagnostic Test: Clinical and biochemical examination.

Detailed Description:
Patients with chronic adrenal insufficiency (AI) are at risk of suffering from life-threatening adrenal crisis (AC), despite established hormone replacement therapies and patient education. Recent retrospective analyses observed different risk factors for AC, e.g. primary AI and comorbidities. Furthermore, patients that already experienced an AC seem to have an increased risk to develop further AC. The aim of the study is to evaluate potential risk factors/predisposing factors for AC in patients with chronic primary and secondary AI (PAI/SAI). Patients with chronic AI are assessed by clinical and biochemical examination and questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor. AI patients with a high frequency of AC will be compared to matched controls (age, sex and cause of AI) with no AC or a low frequency of AC in the past.

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Study Type : Observational
Estimated Enrollment : 71 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Predisposing Factors for the Incidence of Adrenal Crisis in Chronic Adrenal Insufficiency
Actual Study Start Date : November 2015
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
High frequency of adrenal crisis
Patients with a high frequency of adrenal crisis in the past. Intervention: Clinical and biochemical examination (physical examination and blood-sampling before and after oral ingestion of glucocorticoids).
Diagnostic Test: Clinical and biochemical examination.
Patients with chronic adrenal insufficiency were assessed by clinical and biochemical examination as well as questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor.

Low frequency of adrenal crisis
Patients with no adrenal crisis or a low frequency of AC in the past. Intervention: Clinical and biochemical examination (physical examination and blood-sampling before and after oral ingestion of glucocorticoids).
Diagnostic Test: Clinical and biochemical examination.
Patients with chronic adrenal insufficiency were assessed by clinical and biochemical examination as well as questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor.




Primary Outcome Measures :
  1. Chronic inflammation (hsCRP, Interleukin-6) [ Time Frame: 1 day ]
    Measurement of hsCRP (mg/dl) and Interleukin-6 (pg/ml) levels. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis exhibit higher hsCRP and Interleukin-6 levels.

  2. Cortisol metabolism [ Time Frame: 1 day ]
    Measurement of cortisol-levels (mg/dl) before as well as 60 min and 120 min after ingestion of hydrocortisone. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis exhibit a faster hydrocortisone metabolism.

  3. Replacement therapy with glucocorticoids [ Time Frame: 1 day ]
    Evaluation of hormone replacement therapy with glucocorticoids by a clinical score. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis suffer from under-replacement.

  4. Replacement therapy with mineralocorticoids [ Time Frame: 1 day ]
    Evaluation of hormone replacement therapy with mineralocorticoids by a clinical and biochemical assessment. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis suffer from under-replacement.

  5. Glucocorticoid-receptor-polymorphisms [ Time Frame: 1 day ]
    Evaluation of glucocorticoid-receptor-polymorphisms (ER 22/23 EK, N363S, bcl1, 9beta, Tth3l). Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a higher prevalence of glucocorticoid-receptor-polymorphisms.

  6. Catecholamine-levels [ Time Frame: 1 day ]
    Evaluation of catecholamine-levels (ng/l). Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a more pronounced catecholamin-deficit.

  7. Patient education [ Time Frame: 1 day ]
    Evaluation of patient education by questionnaire. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a worse education status.


Biospecimen Retention:   Samples With DNA
Retention of samples with and without DNA (whole-blood and serum).


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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 with chronic adrenal insufficiency under hormone replacement therapy with glucocorticoids.
Criteria

Inclusion Criteria:

  • Age >18 years
  • Patient´s written informed consent
  • Ability to comply with the protocol procedures
  • Patients with chronic primary or secondary adrenal insufficiency under established stable replacement therapy (disease duration at least 2 years)

Exclusion Criteria:

  • Age <18 years
  • Pregnancy or breast feeding
  • Intake of CYP3A4-inducting-drugs

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): NCT03410160


Locations
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Germany
University Hospital Wuerzburg, Dept. of medicine I
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
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Principal Investigator: Stefanie Hahner, MD, Prof. Univesity Hospital Wuerzburg
Publications:
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Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT03410160    
Other Study ID Numbers: PIA
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Wuerzburg University Hospital:
adrenal crisis
predisposing factors
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases