A Randomized Clinical Trial of Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion
Alaa Sada
Summary
Mild Autonomous Cortisol Secretion (MACS) is a condition in which an adrenal gland produces excess cortisol and is associated with high blood pressure, diabetes, and weight gain. Surgical removal of the adrenal gland (adrenalectomy) is standard treatment, but some patients continue to have metabolic health problems after surgery. This randomized study will evaluate whether treatment with tirzepatide after adrenalectomy improves metabolic outcomes in patients with MACS compared with adrenalectomy alone.
Description
This prospective, randomized study will enroll adults with MACS and elevated blood pressure who are undergoing unilateral adrenalectomy. Following surgery, participants will be randomized in a 1:1 ratio to one of two groups: adrenalectomy alone or adrenalectomy followed by tirzepatide therapy for 12 months. Tirzepatide will be prescribed and managed by the study team in accordance with current standard-of-care practices, including routine clinical monitoring and dose adjustments. The primary focus of the study is to evaluate blood pressure control at 12 months. Secondary outcomes include chan…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults aged 18 years and older * Diagnosis of MACS, defined as morning cortisol \>1.8 mcg/dL after a 1 mg dexamethasone suppression test * Elevated blood pressure (SBP ≥120 mmHg or DBP ≥80 mmHg per the 2017 American College of Cardiology/American Heart Association \[ACC/AHA\] criteria, or current use of antihypertensive medication) * BMI ≥27 * Undergoing or having undergone adrenalectomy for the treatment of MACS Exclusion Criteria: * Bilateral adrenal lesions * Adrenal malignancy * Concurrent primary aldosteronism with MACS * Current use of GLP-1 receptor agonists * P…
Interventions
- DrugTirzepatide
Tirzepatide will be initiated at the lowest dose of 2.5 mg once weekly for 4 weeks. The dose will then be titrated every 4 weeks based on patient tolerance to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg.
- OtherStandard medical treatment
Participants will receive postoperative care and follow up per institutional standard-of-care practices
Location
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania