Detecting cortisol secretion issues in patients with adrenal incidentalomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Ricardo Correa, MD — The Cleveland Clinic
• Study coordinator: Kimberly Jenkins
• Email: jenkink@ccf.org
• Phone: 216-445-4791

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adrenal Diseases in Modena: A Patient Registry at Modena University Hospital

  This study collects medical histories and treatment data from patients with adrenal diseases to see how they are diagnosed and managed in Modena.

  Recruiting Azienda Ospedaliero-Universitaria di Modena · Modena, Modena · NCT07920198

• Tirzepatide after adrenalectomy for MACS

  This study tests whether adding tirzepatide after adrenalectomy helps control blood pressure and improve metabolic health in adults with mild autonomous cortisol secretion.

  Recruiting Phase 2 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07573163

• Adrenalectomy versus semaglutide for metabolic health in mild autonomous cortisol secretion

  We are testing whether removing the adrenal gland or treating with semaglutide better improves insulin resistance and other metabolic measures in adults with mild autonomous cortisol secretion, and comparing semaglutide effects to matched adults without adrenal tumors.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT07361874

• Metyrapone versus osilodrostat for metabolic autonomous cortisol secretion (MACS)

  This trial will test whether metyrapone or osilodrostat better lowers cortisol and improves health in adults with mild autonomous cortisol secretion (MACS) who are not having surgery.

  Recruiting Phase 4 Laikο General Hospital, Athens · Athens · NCT07268222

• Isturisa treatment for people with mild autonomous cortisol secretion (MACS)

  This trial will test whether Isturisa (osilodrostat) helps adults with MACS improve metabolic measures, blood pressure, weight, bone density, and quality of life.

  Recruiting Phase 4 Johns Hopkins University · Baltimore, Maryland · NCT07247058

• Metyrapone for Mild Autonomous Cortisol Secretion

  This study tests whether taking metyrapone by mouth for six months can safely reduce cortisol excess in adults with MACS compared with a placebo.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07138274

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.