Prevalence of Adrenal Insufficiency in Kidney Transplanted Patients in Glucocorticoid Treatment

NCT03136562 | Completed DMC

• 1 other identifier: NTx-CSI
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Insufficiency

Outcome Measures

Primary Outcomes (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.

  Cutoff for normal adrenal function: 30 min p-cortisol \>/= 420 nmol/L.

  The time frame of each Synacthen® test is approximately 90 minutes.

Secondary Outcomes (7)

• Registration of history of treatment.

  The registration will take place at the study visit (approximately 90 minutes).

• Quality of life and functional level.

  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.

• 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.

  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.

• Body composition

  After the Synacthen® test the height, weight, waist and hip circumference are measured at the study visit.

• Bone density.

  The results from latest Dxa-scan performed in rutine settings are collected from the patients on the same day as the Synacthen® test.

Study Arms (2)

Kidney transplanted patients

Kidney transplanted patients in prednisolone treatment. Adrenal function is assessed by a synacthen test.

Diagnostic Test: Synacthen test

Control group

Patients in dialysis not in prednisolone treatment. Adrenal function is assessed by a synacthen test.

Diagnostic Test: Synacthen test

Interventions

Synacthen test DIAGNOSTIC_TEST

250 microg synacthen test performed fasting, in the morning. P-cortisol measured before and 30 minutes after Synacthen injection.

Control group; Kidney transplanted patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 kidney transplanted patients and 30 patients in dialysis.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and saliva.

MeSH Terms

Conditions

Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Ulla Feldt-Rasmussen, Professor

  Department of Endocrinology, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, DMSc

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: May 2, 2017
• Study Start: March 20, 2017
• Primary Completion: February 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

DK (1)