Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

Mount Sinai Health System

Status and phase: Completed; Phase 4

Conditions: Mild Hypercortisolism

Treatments: Drug: Mifepristone

Study type: Interventional

Funder types: Other

Identifiers

NCT01990560

GCO 13-1061

Details and patient eligibility

About

The purpose of this study is to determine whether mifepristone is an effective treatment for hyperglycemia due to mild hypercortisolism.

• To test the hypothesis that GR blockade with mifepristone will decrease the severity of metabolic syndrome features as measured by waist circumference, lipid profile, body mass index, blood pressure and insulin resistance, measured by HOMA-IR score.
• To test the hypothesis that GR blockade with mifepristone will improve QoL, depression and anxiety scores, measured by validated assessments, in patients with mild hypercortisolism.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years of age
• Incidentally noted adrenal nodule <4 cm with benign imaging characteristics
• Evidence of mild hypercortisolism
• Evidence of diabetes or abnormal glucose tolerance

Exclusion criteria

• contraindication to mifepristone
• Indication for unilateral adrenalectomy
• Evidence of other adrenal hormone hypersecretion
• lactating mothers
• women of childbearing age unwilling to use an effective, nonhormonal form of contraception

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Mifepristone

Experimental group

Description:

Mifepristone 300mg tablets taken once daily with dose increase of no more than 300mg once monthly and to a maximum dose of 1200mg daily as indicated by symptom response

Treatment:

Drug: Mifepristone