Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
The aim of the proposed study is to estimate the incidence of Mild Autonomous Cortisol Secretion (MACS) in patients with Adrenal Incidentaloma (AI) and evaluate the available diagnostic tests to determine the most sensitive and specific combination of tests for assessing MACS from adrenal adenoma for prediction of the phenotype associated with cortisol excess. As well as following the patients for 4 years and see if anything changes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ages 18 years and older.
Presence of adrenal incidentaloma by cat scan (CT) or magnetic resonance imaging (MRI) examination.
1-mg Dexamethasone suppression test cortisol ≤ 5 μg/dL with adequate dexamethasone level.
Disqualifiers
1-mg Dexamethasone suppression test cortisol > 5 μg/dL with adequate dexamethasone level. Patients who fail to suppress below this level will be considered to have Cushing's syndrome and will be referred for appropriate treatment.
Current or recent (3 months) history of use of glucocorticoid medication (including joint injections of steroids).
History of uncontrolled hypertension or history of hypertension with more than 2 medications.
History of uncontrolled type 2 Diabetes Mellitus or history of diabetes mellitus with A1c>7.5.
Trial population
Subjects will be recruited from Endocrinology patients who have previously undergone dexamethasone suppression testing for Adrenal Incidentaloma (AI) or have been diagnosed with AI and have been seen at the Endocrinology and Metabolism institute (EMI). They will be identified from review the laboratory database and clinical records. All subjects with a dexamethasone suppression test \<5 micrograms/dL will be invited to participate in the study.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Various labs and imaging tests
Diagnostic testDexamethasone Suppression Test, Adrenocorticotropic Hormone (ACTH), Salivary Cortisol Levels, Vasopressin Stimulation test, Fasting Glucose, Fasting Insulin, Complete Metabolic Panel (CMP), Gamma-glutamyl transferase (GGT), Sex Hormone Binding Globulin, Cat scan of abdomen/Pelvis, Whole body dual energy x-ray absorptiometry (DXA) scan, Ultrasound Fibroscan Transient Elastography
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Evaluate best diagnostic test(s)
To evaluate and determine the most sensitive and specific combination of tests for assessing mild autonomous cortisol secreting (MACS) from adrenal adenoma for prediction of the phenotype associated with cortisol excess. Study team will measure cortisol in serum, cortisol in saliva, cortisol in urine, vasopressin stimulation test, 1 mg dexamethasone stimulation test (DST) and a 2 mg DST, Adrenocorticotropic Hormone test (ACTH) and (dehydroepiandrosterone sulfate test) DHEAS. With this, a diagnosis of MACS can be determined. To determine the sensitivity of each the area under the curve (AUC) will be compared with the standard test which is 1 mg DST.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
RECORDATI GROUP
Collaborator
Source ClinicalTrials.gov