RecruitingNCT04543253

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


Sponsor

Mayo Clinic

Enrollment

700 participants

Start Date

Jul 25, 2019

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria2

  • systemic supraphysiological GC for any reason within 1 month of enrollment, for more than 2 weeks,
  • inability to provide informed consent

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Interventions

OTHERMUSE biofeedback

biofeedback through a headband


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT04543253


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