IMPACT-MACS: Adrenalectomy vs Semaglutide for Metabolic Outcomes in Mild Autonomous Cortisol Secretion
Recruiting now · Not applicable
Conditions studied: Mild Autonomous Cortisol Secretion (MACS), Autonomous Cortisol Secretion (ACS), Subclinical Cushing's, Mild Autonomous Cortisol Excess
In brief
The goal of this study is to learn how two treatments-adrenalectomy (surgical removal of an adrenal gland) and semaglutide (a medication used for weight management)-affect insulin resistance and cortisol regulation in adults with mild autonomous cortisol secretion (MACS). The study will also learn how these treatments impact body composition, blood pressure, cholesterol, inflammation, muscle strength, and quality of life. The main questions the study aims to answer are: 1. Does adrenalectomy or semaglutide improve insulin resistance more in people with MACS? 2. How do these treatments change cortisol patterns and other cardiometabolic risk factors? 3. Do people with MACS respond differently to semaglutide compared to matched adults without MACS? Participants will: 1. Receive either adrenalectomy or semaglutide if they have MACS, or semaglutide if they are matched controls 2. Complete clinic visits and phone visits over about 26-30 weeks 3. Undergo metabolic testing such as blood tests, urine steroid profiling, body composition scans, blood pressure monitoring, muscle strength testing, and questionnaires about health and well-being
Key facts
- Study ID
- NCT07361874
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 75
- Starts
- 2026-03-05
- Expected to finish
- 2030-05-31
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults ≥18 years
- MACS groups: adrenal adenoma + DST cortisol >1.8 µg/dL + no overt Cushing + eligible for adrenalectomy
- Willingness to postpone surgery 6 months if randomized
- Controls: no adrenal abnormalities + normal DST + BMI ≥27 + ≥2 cardiometabolic conditions
- Stable medication doses for ≥4 weeks
- Negative pregnancy test if applicable
You may not qualify if…
- Prior GLP-1 RA within 90 days
- Weight change >5 kg in past 90 days
- Prior obesity/diabetes surgery
- Type 1 diabetes or other diabetes types
- Severe organ disease
- Recent pancreatitis
- Pregnancy, breastfeeding
- Contraindication to semaglutide
- Contraindication to surgery delay
- Chronic glucocorticoid use
Where it is running
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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