RecruitingNCT06344143

Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma


Sponsor

The Cleveland Clinic

Enrollment

20 participants

Start Date

Nov 20, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria3

  • Patients ages 18 years and older.
  • Presence of adrenal incidentaloma by cat scan (CT) or magnetic resonance imaging (MRI) examination.
  • mg Dexamethasone suppression test cortisol ≤ 5 μg/dL with adequate dexamethasone level.

Exclusion Criteria14

  • 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.
  • Known History of osteoporosis
  • Documented Clinical Cushing's disease.
  • Clinical suspicion of adrenal carcinoma.
  • History of alcohol abuse/dependence.
  • History of cirrhosis of liver.
  • History of hepatitis B or C infection regardless of treatment.
  • History of type 1 diabetes.
  • History of hemochromatosis.
  • History of autoimmune hepatitis.
  • History of Wilson's disease.

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Interventions

DIAGNOSTIC_TESTVarious labs and imaging tests

Dexamethasone 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


Locations(1)

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

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NCT06344143


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