Metyrapone for Mild Autonomous Cortisol Secretion (MACS)

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria: - Provide written informed consent. - Stated willingness to comply with all study procedures and availability for the duration of the study. - Diagnosed with MACS: at least 2 abnormal post-dexamethasone cortisol results (1 mg post-dexamethasone cortisol > 1.8 mcg/d; or 8 mg post-dexamethasone cortisol > 1 mcg/dL) and historical dexamethasone suppression test results can be used if performed within 24 months prior to enrollment. - Adrenal imaging phenotype consistent with benign disease (adrenal adenoma/s, macronodular or micronodular adrenal hyperplasia). - At least one of the following comorbidities: obesity (BMI > 30 kg/m^2); dysglycemia; dyslipidemia; hypertension; osteopenia; osteoporosis; fragility fractures. - Ability to take oral medication and be willing to adhere to the study intervention regimen. - For females of reproductive potential: use of highly effective contraception initiated prior to baseline visit and for 1 month after completing metyrapone study. - For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of <5% per year during the treatment period and for 6 months after the last dose of study treatment. - Stable timing for bedtime for at least one week prior to on-site study visits Exclusion Criteria: - Planned alternative therapy for MACS within 6 months after joining the study. - Current use of oral exogenous glucocorticoid therapy. - Current use of opioid therapy > 20 MME/day. - Planned use of oral exogenous glucocorticoid therapy. - Planned use of opioid therapy > 20 MME/day. - Use of injectable glucocorticoid within the last 6 weeks. - Investigator's judgement based on history/physical examination that a comorbidity or concomitant medication may impact the hypothalamic-pituitary-adrenal axis or steroid metabolome. - Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness/social situations that would limit compliance with study requirements. - Pregnancy or lactation. - Known allergic reactions to metyrapone. - Suspected false positive post-dexamethasone cortisol results due to increased metabolism, poor absorption, or noncompliance with dexamethasone. - Treatment with another investigational drug or other intervention within lower than specific therapy washout period.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events

Secondary Outcome Measures

Name	Time	Method

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eiden University Medical Center

Updated 3/19/2012