IMPACT-MACS: Adrenalectomy vs Semaglutide for Metabolic Outcomes in Mild Autonomous Cortisol Secretion
A legfontosabb adatok
- Hol
- Dallas (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- University of Texas Southwestern Medical CenterDallas, Egyesült ÁllamokContact: Oksana Hamidi, DO, MSCSRésztvevőt keres
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- Megtarthatom a saját orvosomat?
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University of Texas Southwestern Medical Center
- Azonosító
- NCT07361874
- A regiszteradat frissítve
- 2026. március 27.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
IMPACT-MACS Study: Investigating the Mechanisms, Pathophysiology, and Cardiometabolic Treatment in Mild Autonomous Cortisol Secretion
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
Bevonási feltételek: 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.
Kizáró feltételek: Prior GLP-1 RA within 90 days; Prior obesity/diabetes surgery; Contraindication to surgery delay; Type 1 diabetes or other diabetes types; Severe organ disease; Weight change >5 kg in past 90 days; Recent pancreatitis; Pregnancy, breastfeeding; Contraindication to semaglutide; Chronic glucocorticoid use.