Prevalence of Adrenal Insufficiency in Kidney Transplanted Patients in Glucocorticoid Treatment
NCT ID: NCT03136562
Last Updated: 2023-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2017-03-20
2019-06-01
Brief Summary
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Development of glucocorticoid-induced adrenal insufficiency is a serious adverse effect to glucocorticoid treatment. The study includes a control group of patients with kidney failure currently treated in dialysis, who are not in glucocorticoid treatment.
Individual genotyping is performed to determine the haplotype of glucocorticoid receptor polymorphisms: N363 S, BclI, ER23/23EK and 9β in all the patients with the purpose of investigating this as a risk factor for the development of adrenal insufficiency. The hypothesis is that subjects with one or another of the polymorphisms in the glucocorticoid receptor gene will either have increased or diminished glucocorticoid sensitivity.
Using validated questionnaires assessing the quality of life and functional level of the patients enrolled in the study we aim to establish a link between functional level and biochemically proven adrenal insufficiency.
Other secondary outcomes in the study includes bloodpressure, body composition, bone density, metabolic syndrome, inflammation and salivary cortisol profiles.
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Detailed Description
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Cut-off for normal adrenal function is locally validated assay specific cut-off of 30 min P-cortisol \>420 nmol/l. The primary outcome measure of this study is P-cortisol concentrations 30 minutes after Synacthen® injection in prednisolone treated patients compared with comtrols. Secondary, 30 minutes P-cortisol is examined in relation to glucocorticoid receptor haplotypes.
The genotyping is determined using polymerase chain reaction (PCR).
The questionnaires used in this study includes EQ-5D, SF-36, Patient Life Situation Form, CushingQol and ADDOQol.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Kidney transplanted patients
Kidney transplanted patients in prednisolone treatment. Adrenal function is assessed by a synacthen test.
Synacthen test
250 microg synacthen test performed fasting, in the morning. P-cortisol measured before and 30 minutes after Synacthen injection.
Control group
Patients in dialysis not in prednisolone treatment. Adrenal function is assessed by a synacthen test.
Synacthen test
250 microg synacthen test performed fasting, in the morning. P-cortisol measured before and 30 minutes after Synacthen injection.
Interventions
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Synacthen test
250 microg synacthen test performed fasting, in the morning. P-cortisol measured before and 30 minutes after Synacthen injection.
Eligibility Criteria
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Inclusion Criteria
* Kidney transplated patients or patients with kidney failure treated in dialysis.
* Prednisone min 5 mg/day max 7,5 mg/day for the kidney transplanted patients (control group not treated with prednisone).
Exclusion Criteria
* Anemia with hemoglobin level less than 6,5 mmol/L.
* Not willing to pause any oestrogen tratment for a minimum of 6 weeks.
* Pregnancy.
* Not understanding Danish language or otherwise not able to provide a written informed concent.
18 Years
80 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Ulla Feldt-Rasmussen
Professor, MD, DMSc
Principal Investigators
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Ulla Feldt-Rasmussen, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Endocrinology, Rigshospitalet
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Other Identifiers
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NTx-CSI
Identifier Type: -
Identifier Source: org_study_id
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