Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT06344143

Conditions

Mild Autonomous Cortisol Secretion (MACS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Various labs and imaging tests

Study Details

Brief 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.

Conditions

Mild Autonomous Cortisol Secretion (MACS)

Study ID

NCT06344143

Start date

Nov 20, 2024

Status verified date

Jan, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients ages 18 years and older.
2. Presence of adrenal incidentaloma by cat scan (CT) or magnetic resonance imaging (MRI) examination.
3. 1-mg Dexamethasone suppression test cortisol ≤ 5 μg/dL with adequate dexamethasone level.

Exclusion Criteria:

1. 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.
2. Current or recent (3 months) history of use of glucocorticoid medication (including joint injections of steroids).
3. History of uncontrolled hypertension or history of hypertension with more than 2 medications.
4. History of uncontrolled type 2 Diabetes Mellitus or history of diabetes mellitus with A1c>7.5.
5. Known History of osteoporosis
6. Documented Clinical Cushing's disease.
7. Clinical suspicion of adrenal carcinoma.
8. History of alcohol abuse/dependence.
9. History of cirrhosis of liver.
10. History of hepatitis B or C infection regardless of treatment.
11. History of type 1 diabetes.
12. History of hemochromatosis.
13. History of autoimmune hepatitis.
14. History of Wilson's disease.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Interventions

Various 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

Primary outcome measure

  • Evaluate best diagnostic test(s) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-01-08.