Detecting cortisol secretion issues in patients with adrenal incidentalomas

Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma

This study is trying to see how common mild cortisol secretion problems are in people with adrenal incidentalomas and which tests work best to find them.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06344143 on ClinicalTrials.gov

What this trial studies

This observational study aims to estimate the incidence of Mild Autonomous Cortisol Secretion (MACS) in patients diagnosed with adrenal incidentalomas. It evaluates various diagnostic tests to identify the most sensitive and specific combinations for assessing MACS and differentiating it from adrenal adenomas. Patients will be followed for four years to monitor any changes in their condition. The study seeks to understand the potential adverse health outcomes associated with MACS, including metabolic syndrome and cardiovascular issues.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with adrenal incidentalomas identified through imaging.

Not a fit: Patients with cortisol levels above the specified threshold indicating Cushing's syndrome or those with uncontrolled hypertension or diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods and treatment options for patients with MACS, potentially reducing associated health risks.

How similar studies have performed: While the approach to diagnosing MACS in adrenal incidentalomas is being explored, the specific combination of tests and long-term follow-up in this context is relatively novel.

Eligibility criteria

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.

Where this trial is running

Cleveland, Ohio

• The Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Ricardo Correa, MD — The Cleveland Clinic
• Study coordinator: Kimberly Jenkins

Conditions Mild Autonomous Cortisol Secretion