Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

Completed · Phase 4

Conditions studied: Mild Hypercortisolism

In brief

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.

Key facts

Study ID

NCT01990560

Run by

Icahn School of Medicine at Mount Sinai

People needed

8

Starts

2013-11-01

Expected to finish

2016-09-01

Last updated by the study team

2018-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >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

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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