Adrenalectomy vs Semaglutide for Autonomous Cortisol Secretion
(IMPACT-MACS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two treatments—adrenalectomy (surgical removal of an adrenal gland) and semaglutide (a medication for weight management)—affect people with mild autonomous cortisol secretion (MACS). Researchers aim to determine which treatment better improves insulin resistance and how they alter cortisol levels and other health factors like blood pressure and muscle strength. Participants with MACS will either undergo surgery or take semaglutide, while a control group without adrenal issues will also take semaglutide. Ideal candidates are adults with a known adrenal gland issue and mild cortisol imbalance, or those without adrenal issues but with cardiometabolic conditions like high blood pressure.
As an unphased trial, this study provides a unique opportunity to enhance understanding of treatment options for MACS.
Will I have to stop taking my current medications?
The trial requires that your medication doses have been stable for at least 4 weeks before joining. It doesn't specify if you need to stop any current medications, but you should discuss your specific situation with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that semaglutide is generally safe for use. Studies have found it effective for weight loss and other conditions, with a well-established safety record. Some individuals might experience mild side effects like nausea or vomiting, but these are usually manageable.
Adrenalectomy, the surgery to remove an adrenal gland, has been used for a long time. It is a standard treatment for certain conditions, and its safety is well-established.
Both treatments have been safely used in people. For specific questions about how these treatments might affect you, consult a healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for managing mild autonomous cortisol secretion (MACS) because they offer distinct approaches. Adrenalectomy, a surgical option, directly removes the adrenal gland, potentially resolving the source of excessive cortisol production. In contrast, semaglutide, a medication typically used for weight management, is being investigated for its ability to regulate cortisol levels without surgery. This drug offers a non-invasive alternative, which might be appealing for those who are not suitable candidates for surgery or prefer a medical approach. The combination of these options could provide more personalized treatment plans based on individual patient needs and responses.
What evidence suggests that this trial's treatments could be effective for mild autonomous cortisol secretion?
This trial compares the effects of adrenalectomy and semaglutide on individuals with mild autonomous cortisol secretion (MACS). Research has shown that removing an adrenal gland through surgery, known as adrenalectomy, can improve various health outcomes in people with MACS, potentially balancing insulin levels and reducing issues related to cortisol, a stress hormone. Meanwhile, semaglutide, a medication often used for weight loss, has shown promise in helping people lose weight and manage cortisol levels. One study found that using semaglutide with another treatment led to significant weight loss and normalized cortisol levels. This trial studies both treatments to assess their impact on insulin resistance, cortisol patterns, and other health factors in people with MACS. This research offers hope that either option could provide meaningful benefits.16789
Are You a Good Fit for This Trial?
This trial is for adults over 18 with mild autonomous cortisol secretion (MACS), who have an adrenal adenoma, no severe Cushing's syndrome, and are eligible for surgery. They must be willing to delay surgery if randomized and on stable medication doses. Controls without adrenal issues but with obesity and at least two cardiometabolic conditions can also join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either adrenalectomy or semaglutide for 26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Adrenalectomy
- Semaglutide
Trial Overview
The study compares the effects of adrenalectomy (surgical removal of one adrenal gland) versus semaglutide (a weight management drug) on insulin resistance in people with MACS. It will assess changes in body composition, blood pressure, cholesterol levels, inflammation markers, muscle strength, and overall quality of life.
How Is the Trial Designed?
3
Treatment groups
Active Control
Matched adults without adrenal tumors receive semaglutide using the same dosing schedule as MACS participants. This arm allows comparison of semaglutide responses between individuals with and without cortisol dysregulation.
Adults with mild autonomous cortisol secretion (MACS) who are clinically eligible for adrenalectomy undergo unilateral adrenalectomy as part of standard care. Participants complete all metabolic assessments before and after treatment.
Adults with MACS receive once-weekly semaglutide for 26 weeks using FDA-approved weight-management dosing. Participants undergo the same assessments as the surgery group.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
IMPACT-MACS: Adrenalectomy vs Semaglutide for ...
This single-center, prospective, interventional study evaluates metabolic responses to surgical versus medical treatment in adults with mild ...
Increased Weight Loss With the Combination of ...
The patient lost an additional 47 lbs, resulting in a total weight loss of 89 lbs while on levoketoconazole and semaglutide, and the cortisol levels normalized.
Randomized trial studying metabolic outcomes and quality of ...
Randomized trial studying metabolic outcomes and quality of life after adrenalectomy versus conservative management for mild autonomous cortisol secretion.
4.
hcplive.com
hcplive.com/view/macs-linked-to-increased-hypertension-risk-need-for-insulin-therapy-in-diabetesMACS Linked to Increased Hypertension Risk, Need for ...
A recent analysis found patients with benign adrenal tumors and MACS were at an increased risk of cardiometabolic diseases.
5.
researchgate.net
researchgate.net/publication/392608470_Multidisciplinary_Team-Based_Management_and_Outcomes_of_Patients_with_Mild_Autonomous_Cortisol_Secretion(PDF) Multidisciplinary Team-Based Management and ...
Multidisciplinary Team-Based Management and Outcomes of Patients with Mild Autonomous Cortisol Secretion. AVES Publishing. Endocrinology ...
Increased Weight Loss With the Combination of ...
The patient lost an additional 47 lbs, resulting in a total weight loss of 89 lbs while on levoketoconazole and semaglutide, and the cortisol levels normalized.
Cardiometabolic risk and therapeutic outcomes in mild ...
Abstract. Purpose of review: Adrenal tumors are increasingly detected due to widespread use of cross-sectional imaging, with mild autonomous cortisol secretion ...
8.
researchgate.net
researchgate.net/publication/383583862_Pre-Surgery_Cortisol_Levels_as_Biomarker_of_Evolution_after_Bariatric_Surgery_Weight_Loss_and_Weight_RegainPre-Surgery Cortisol Levels as Biomarker of Evolution after ...
We evaluated total weight loss (TWL) ≥ 30% at 1 year and WR after 2 years as an increase of ≥10% of the maximum weight lost. Results: In total, ...
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