Clinical Trial: Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Glucocorticoid Receptor Blockade With Mifepristone in Patients With Mild Adrenal Hypercortisolism

Brief 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.

Detailed Summary:
Sponsor: Icahn School of Medicine at Mount Sinai

Current Primary Outcome: hyperglycemia [ Time Frame: 6 months ]

Improvement in hyperglycemia - fasting glucose, HbA1c, HOMA-IR (a validated assessment of insulin resistance, HOMA-IR = (glucose md/dl x insulin mg/dl)/405)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Metabolic Syndrome [ Time Frame: 6 months ]
    Improvement in metabolic syndrome - outcomes include cortisol, fasting lipid profile, weight, BMI (kg/m2), waist circumference (in centimeters), and blood pressure
  • Quality of Life [ Time Frame: 6 months ]
    Improvement in Quality of Life - completion of 3 validated QoL questionnaires (Cushing's Quality of Life questionnaire (CushingQoL), Nottingham Health Profile (NHP), and Hospital Anxiety and Depression Scale (HADS)), and the visual analogue scale (VAS) to quantify appetite. Patients will also complete the Beck Depression Inventory and the State Trait Anxiety Inventory (STAI).


Original Secondary Outcome: Same as current

Information By: Icahn School of Medicine at Mount Sinai

Dates:
Date Received: November 15, 2013
Date Started: November 2013
Date Completion:
Last Updated: September 29, 2016
Last Verified: September 2016