CompletedPhase 4

Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

United States8 participantsStarted 2013-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

A1C Level

Timeframe: Baseline, 3 months, and 6 months

HOMA-IR

Timeframe: Baseline and 6 months

Trial details

NCT IDNCT01990560

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

Results submitted2017-10-18

View on ClinicalTrials.gov More Mild Hypercortisolism trials