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Prevalence of Adrenal Insufficiency in Kidney Transplanted Patients in Glucocorticoid Treatment

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ClinicalTrials.gov Identifier: NCT03136562
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark

Brief Summary:

The primary purpose of this study is to determine the prevalence of adrenal insufficiency in a population of patients with kidney transplants receiving low dose prednisone treatment.

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.


Condition or disease Intervention/treatment
Adrenal Insufficiency Diagnostic Test: Synacthen test

Detailed Description:

Adrenal function is assessed in 30 prednisolon treated kidney transplanted patients and compared with 30 patients in dialysis, who are not treated with glucocorticoids. Adrenal function is evaluated using a 250µg Synacthen® test, performed fasting, in the morning, 48 h after the last prednisolone dose.

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.


Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Adrenal Insufficiency in Kidney Transplanted Patients (NTx) in Glucocorticoid Treatment
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : June 1, 2019


Group/Cohort Intervention/treatment
Kidney transplanted patients
Kidney transplanted patients in prednisolone treatment. Adrenal function is assessed by a synacthen test.
Diagnostic 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.
Diagnostic Test: Synacthen test
250 microg synacthen test performed fasting, in the morning. P-cortisol measured before and 30 minutes after Synacthen injection.




Primary Outcome Measures :
  1. The primary outcome measure of this study is the result of the Synacthen® test using primarily the level of P-cortisol 30 minutes after the injection of synacthen. [ Time Frame: The time frame of each Synacthen® test is approximately 90 minutes. ]
    Cutoff for normal adrenal function: 30 min p-cortisol >/= 420 nmol/L.


Secondary Outcome Measures :
  1. Registration of history of treatment. [ Time Frame: The registration will take place at the study visit (approximately 90 minutes). ]
    History of treatment with prednisone and other types of glucocorticoids to examine dosage and time of treatment as risk factors.

  2. Quality of life and functional level. [ Time Frame: Patients receive and fill out the questionnaires prior to their arrival at the study visit and hand them in after the Synacthen® test. Patients receive questionnaires either by mail or at one of their visits in the out patient clinic. ]
    Assessed in all patients enrolled in the study using validated questionnaires as a means to establish a link between functional level and biochemically proven adrenal insufficiency.

  3. Determination of the specific type of glucocorticoid receptor using genotyping in all the patients with the purpose of investigating this as a risk factor for the development of adrenal insufficiency. [ Time Frame: Blood for genotyping is sampled from each patient at the study visit during the Synacthen® test. The blood samples are stored frozen and analyzed concurrently. ]
    Patients are genotyped for 4 polymorphisms (9 beta, ER22/23EK, Bcl1 and N363S) of the glucocorticoid receptor.

  4. Body composition [ Time Frame: After the Synacthen® test the height, weight, waist and hip circumference are measured at the study visit. ]
    Height, weight, waist and hip circumference.

  5. Bone density. [ Time Frame: The results from latest Dxa-scan performed in rutine settings are collected from the patients on the same day as the Synacthen® test. ]
    Results from Dxa-scan.

  6. Metabolic syndrome. [ Time Frame: The waistline and blood pressure are measured at the study visit after the Synacthen® test. The blood samples are collected as part of the test and analyazed on the same day. ]
    Waistline, triglyceride level, HDL cholesterol level, blood pressure and fasting blood sugar is assessed in all the patients.

  7. Salivary cortisol profiles. [ Time Frame: Saliva is sampled from each patient at the study visit as part of the Synacthen® test. The samples are stored frozen and analyzed concurrently after all 60 Synacthen® tests have been performed. ]
    Cortisol concentration in saliva.


Biospecimen Retention:   Samples With DNA
Whole blood and saliva.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
30 kidney transplanted patients and 30 patients in dialysis.
Criteria

Inclusion Criteria:

  • Adult patients (>18 years).
  • 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:

  • Other major organ disease.
  • 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.

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): NCT03136562


Contacts
Contact: Ulla Feldt-Rasmussen, Professor +45 35451023 ufeldt@rh.dk

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Ulla Feldt-Rasmussen, Professor    +4535451023    ufeldt@rh.dk   
Principal Investigator: Ulla Feldt-Rasmussen, Professor         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Ulla Feldt-Rasmussen, Professor Department of Endocrinology, Rigshospitalet

Responsible Party: Ulla Feldt-Rasmussen, Professor, MD, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03136562     History of Changes
Other Study ID Numbers: NTx-CSI
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Glucocorticoids
Epinephrine
Racepinephrine
Epinephryl borate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents