Recovery From Cushing Syndrome and Mild Autonomous Cortisol Secretion (MACS)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Cushing syndrome (CS) is an endocrine disorder caused by chronic exposure to glucocorticoid (GC) excess. Endogenous CS has an estimated incidence of 0.2 to 5.0 cases per million per year and prevalence of 39 to 79 cases per million in various populations. CS usually affects young women, with a median age at diagnosis of 41.4 with a female-to-male ratio of 3:1. Following a curative surgery for CS, patients develop adrenal insufficiency and require GC replacement postoperatively until the hypothalamic-pituitary-adrenal (HPA) axis recovery occurs. Factors, such as age, gender, BMI, subtypes of CS, duration of symptoms, clinical and biochemical severity and postoperative GC dose have been reported to affect the HPA recovery in small retrospective studies. Glucocorticoid withdrawal syndrome (GWS) is a withdrawal reaction due to decrease in supraphysiological GC concentrations, which occurs after a successful surgery of CS. Glucocorticoid withdrawal syndrome (GWS) is under-recognized entity in patients undergoing curative surgery for endogenous Cushing syndrome. In this study we aim to determine pre- and post-surgical predictors of the duration and severity of glucocorticoid withdrawal in patients undergoing a curative surgery for cortisol excess and assess the effect of MUSE intervention on GWS severity in patients undergoing curative surgery for CS as compared to standard of care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• age 18 and above,

• new diagnosis of CS of any of the three subtypes (pituitary, adrenal or ectopic CS), and MACS,

• planning for a curative surgery

• ability to provide informed consent.

Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
Vanessa Fell, MA
fell.vanessa@mayo.edu
507-266-6068
Time Frame
Start Date: 2019-07-25
Estimated Completion Date: 2030-12
Participants
Target number of participants: 700
Treatments
Standard of care CS
Patients undergoing curative surgery for any type of CS who will be followed through standard of care after surgery
MUSE intervention CS
Patients undergoing curative surgery for any type of CS who will be introduced to and provided MUSE for use after surgery
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov