Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Glucocorticoids; Mifepristone

Criteria

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