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Appropriate Limit Value for 1 mg DST in Patients With Chronic Renal Failure

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: NCT05568602
Recruitment Status : Completed
First Posted : October 5, 2022
Last Update Posted : October 5, 2022
Sponsor:
Information provided by (Responsible Party):
Marmara University

Brief Summary:
In this study, we aimed to determine a specific cut-off value for 1mg DST to prevent false positivity usually seen in CRF patients according to the standard cut-off value of 1.8 mcg/dl.

Condition or disease Intervention/treatment
Cushing Syndrome Diagnostic Test: Dexamethasone suppression test

Detailed Description:

Chronic renal failure (CRF) can cause false positivity of overnight 1 mg dexamethasone suppression test (1 mg DST) in whom suspicious for Cushing Syndrome due to variability in dexamethasone bioavailability, increased cortisol secretion, disruption of diurnal rhythm, imbalance in free and bound cortisol levels because of decreased protein levels in CRF patients. In this study, we aimed to determine a specific cut-off value for 1mg DST to prevent false positivity usually seen in CRF patients according to the standard cut-off value of 1.8 mcg/dl.

The data of 1038 patients who applied to Marmara University endocrinology outpatient clinic between January 01, 2018, and December 31, 2019, and who were asked for 1 mg DST were retrospectively scanned from the hospital information and management system. The patients were divided into 4 groups according to their glomerular filtration rates (GFR). 1 mg DST results were evaluated according to GFR and ROC analysis was applied to determine the new limit value for the group whose GFR < 30 ml/min / 1.73m2 In patients classified as Group IV (the patient's GFR below 30 ml/min / 1.73m2) both 1 mg DST median and Pseudocushing Syndrome incidence were significantly higher than in other groups. The new cut-off value was found to be 3.2 mcg/dl with 100% Sensitivity and 92% specificity.

This is the first study determining a specific limit value for 1 mg DST in CRF patients with GFR below 30 ml/min / 1.73m2 to avoid false positivity in these patients. Further studies are needed in more patients on hemodialysis to check the clinically more accurate 1 mg DST cutoff value in this specific population.

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Study Type : Observational
Actual Enrollment : 1034 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Determination of Appropriate Limit Value for Low Dose Dexamethasone Suppression Test in Patients With Chronic Renal Failure
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : August 1, 2021


Group/Cohort Intervention/treatment
GFR<30 ml/min
Patients screened for hypercortisolism and GFR<30ml/min
Diagnostic Test: Dexamethasone suppression test
1 mg Dexamethasone overnight suppression test for screening of hypercortisolism

GFR>30 ml/min
Patients screened for hypercortisolism and GFR>30ml/min
Diagnostic Test: Dexamethasone suppression test
1 mg Dexamethasone overnight suppression test for screening of hypercortisolism




Primary Outcome Measures :
  1. cut-off value for DST [ Time Frame: 1 year ]
    to determine specific cut point for 1mg DST in chronic renal failure



Information from the National Library of Medicine

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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
Between 01 January 2018 and 31 December 2019, 2173 patients who were admitted to the outpatient clinic of our hospital's Endocrine and Metabolic Diseases Department and requested 1 mg DST were included in the screening.
Criteria

Inclusion Criteria:

  • Between 01 January 2018 and 31 December 2019, 2173 patients who were admitted to the outpatient clinic of our hospital's Endocrine and Metabolic Diseases Department and requested 1 mg DST were included in the screening.

Exclusion Criteria:

  • Being under 18 years of age
  • Liver cirrhosis and /or 3-fold or more increase in liver enzymes
  • Use of drugs known to interact with dexamethasone (psychotropic agents, oral contraceptives, anti-epileptic drugs, barbiturates, etc.)
  • An adrenal nodule or pituitary adenoma is detected, but it is at the stage of evaluation whether it is functional or not
  • Typical CS clinical findings (such as Purple stria, Buffalo Hump, moon face)
  • Having an adrenal nodule or pituitary adenoma and being followed by an external center
  • Lack of access to be analyzed information in the study: Albumin, AST, ALT, creatine, white blood cell (WBC), C-Reactive Protein (CRP), glycosylated hemoglobin percentage (HBA1c), glucose, sodium, potassium, thyroid stimulating hormone (TSH), body mass index (BMI), known disease and drug use information, lipid profile tests and information, lack of access to the patient's previous data
  • Having a diagnosis of severe major depression
  • Previously diagnosed with Cushing Syndrome or operated with this diagnosis
  • Prominent hypoalbuminemia (albumin <3 g / dl)

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): NCT05568602


Locations
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Turkey
Özlem ÜSTAY
Istanbul, Pendik, Turkey, 34899
Sponsors and Collaborators
Marmara University
Investigators
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Study Director: Özlem ÜSTAY Marmara University
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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT05568602    
Other Study ID Numbers: OzlemUstay3
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marmara University:
cushing, dexamethasone suppression test, chronic renal failure
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Cushing Syndrome
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents